Episode Transcript
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Speaker 1 (00:11):
From the LAP one hundred studios in southern California, wherever
you're watching, wherever you are listening. If there's a big miss,
show home members having a great day to continue this
crazy ride hopstaff, Very Regodlin, Greg totter Off for Greg,
Oh my.
Speaker 2 (00:29):
God, no, everything I do. We're fighting when the show
starts rolling.
Speaker 3 (00:35):
We're TV a couple different days this week with the
Inside Baseball Gotcha anomaly?
Speaker 4 (00:40):
Right? Yeah, okay?
Speaker 2 (00:42):
Can I yes, you're assuming that I'm dumb.
Speaker 4 (00:46):
I assume that you're.
Speaker 2 (00:48):
I have a reason. Our Emmy Award winning director. You
just were talking to him about he's taking a little
family vacation. So my question was, is there a reason
why we would maybe one to change the dates next week? Also,
do you think we have because we love our award
winning director, don't we?
Speaker 4 (01:04):
Don't you think we have that covered before he takes.
Speaker 2 (01:06):
Some That was my question. It was simply a question.
Speaker 4 (01:08):
Do you wonder about stuff like this?
Speaker 2 (01:09):
Jared give my back here?
Speaker 4 (01:11):
Do you wonder abut stuff like this? No? I like
to stay women.
Speaker 5 (01:14):
Oh my god, oh.
Speaker 4 (01:18):
My god. I could not live without Mary, just the
way I was raised.
Speaker 3 (01:24):
I can't live with Mary, you know, Lane what they
say men can't live with them, can't live with them?
Speaker 1 (01:30):
Do you know what would happen they say about women
can't live live with them?
Speaker 4 (01:35):
Pass the beer nuts? Oh my God, Mary, I love you, I.
Speaker 5 (01:42):
Love I couldn't organizations without.
Speaker 4 (01:52):
God doesn't feel like a Monday at all. Good lord, Okay,
it's a time change. Was thinking about just sinking them out.
Speaker 3 (02:01):
About having you sing background vocal on one of the
songs I got to do at a show.
Speaker 2 (02:07):
Absolutely not.
Speaker 4 (02:08):
Would you you would jump at that chance? This? Okay,
you have a lovely but she's got a really good voice.
Speaker 2 (02:15):
I don't. I only do when you're at the lamp
lader in a dark bar, four cocktails in that don't
have a lovely voice, So.
Speaker 4 (02:21):
Do you not?
Speaker 3 (02:22):
Would you not enjoy going to carry ok anywhere unless
you think you don't like to sing and perform anymore?
Speaker 2 (02:27):
No? I will with at the pan I went to
a piano bar and Cardiff last week and we sang
at the top of.
Speaker 4 (02:36):
Cuchuch No, it's it's it's it's a great.
Speaker 2 (02:39):
Italian It's fantastic, so any funny.
Speaker 3 (02:42):
So I went up there and actually had dinner and
they called me up and I had maybe been over
served by a few and they had me up there
to play piano with the guy and and so I
took it great.
Speaker 4 (02:52):
But but it's one of those places where.
Speaker 3 (02:54):
This guy takes requests, and it's one of those piano
bar places that's a little cheeseball because it's the crowds
between let's say forty five and nine and sixty.
Speaker 4 (03:03):
Five, Yeah, right in and they're saying.
Speaker 2 (03:05):
Hey, don't stop, believe it that I may have to
show it in the next break. I'll show a clip
of us singing maybe that exact song or oh no,
sweet Caroline, I may.
Speaker 4 (03:16):
I may have a clip of mine too.
Speaker 3 (03:18):
Howie font is here and there is one point six
four four trillion auto loans dollars, not a loans in
the US, almost a bunch of student loan debt.
Speaker 4 (03:26):
This is so funny that you say that, Howie. And
I'm gonna.
Speaker 3 (03:28):
I'm gonna because remember when Joe Biden was going to
forgive student loan debt.
Speaker 4 (03:38):
Yes, I did this.
Speaker 3 (03:40):
I did this topic on on talk radio and I said,
you know, only twenty percent of the population even has
student loan debt. And of the people that go to college,
I think it's only half of the people college have
student loan debt, but there are close to eighty percent
of our population adult population that has a car loan. Yes,
it's about the same. Now, why do you go to
(04:01):
school to get to work? Why do you get a
car loan to get to work? If you're going to
forgive anything, why not forgive car loans for the entire
country as opposed to forgiving student loan debt. And I
know this is not what this is about, but I thought, boy,
if we're talking about giving twenty four billion dollars in Ukraine, how.
Speaker 4 (04:22):
About kicking out a million bucks apiece to the families
here in the US.
Speaker 3 (04:25):
You can do that, right, I mean, and I realized
that would cave the economy and cause rampant inflation. But Howie,
and I know, I know that this is sort of
not the topic you were going to talk about. But
I read this and because you bring up student loan
debt as a as a as a comparer, and I
think the real story here is just how much how
much debt we're in. But wouldn't you think as a
(04:46):
campaign promise, Donald Trump should have rolled in and said, hey,
forget the student loan debt no more Carlos, could you.
Speaker 2 (04:56):
How he's going to run on that and we.
Speaker 6 (05:01):
That wouldn't be paid?
Speaker 4 (05:01):
How much is what is the average? So how we
take us to the Carlin and Steff?
Speaker 3 (05:07):
What is the average debt for Carlos six six thousand,
average income sixty six thousand, two hundred for family for
six twenty two. Talk about this whole thing because one
point six trillion in auto loans, in student auto loans,
one point seven trillion student loans, it's about the same thing.
Speaker 7 (05:22):
But talk like you said, this is a This is
a form of debt and a piece of people's finances
that affects them in a much broader way than even
student loan debt, which I think is why it's a
good comparison.
Speaker 8 (05:33):
So I thought it was important to talk.
Speaker 7 (05:35):
About some of the solutions maybe and then how the
big the scope of the problem is.
Speaker 6 (05:39):
So this is.
Speaker 7 (05:40):
About thirteen percent of the average in the average income,
like you said, sixty six thousand dollars, and the average
car loan payment is thirteen percent of debt, So it's
very significant. What say a new car you're spending six
hundred and forty dollars a month or seven hundred and
forty dollars a month.
Speaker 8 (05:58):
Oh you five to one least five eighty. So this
is this is big stuff you us.
Speaker 3 (06:04):
You have mortgages here and then car loans or second
right in terms of in terms of.
Speaker 8 (06:08):
In terms of overall debt, that's right.
Speaker 3 (06:09):
Yeah, the the uh uh seven hundred new car loans
seven and three dollars a month, up seven last year.
Speaker 4 (06:18):
Least cars you said five? Any one? What's the delinquency rate?
How late are we in our car patements? Is what
I want to know.
Speaker 7 (06:24):
So the average duration of car loan is actually five
and a half years, which is pretty substantial.
Speaker 6 (06:30):
Uh.
Speaker 7 (06:30):
And the thing we all know about cars is that
it's an appreciating asset, so you don't need that you.
Speaker 4 (06:36):
Drive it off the drive. It just creates you what
is it?
Speaker 8 (06:41):
And you and have obligations to it on average for
five and a half years.
Speaker 7 (06:44):
That's pretty crazy. And so we're seeing in the the economy.
One of the ways we measure, you know, the strength
of the consumer is credit card delinquency rates and other
loan delinquency rates, and for car loans it's up seventeen
percent just last year.
Speaker 3 (06:59):
What's interesting, ninety percent bar was paying more than a
thousand dollars. But but here's what I want to know.
Speaker 2 (07:04):
Is this terrofts And I'm just reading this, this is scary.
Speaker 3 (07:07):
Talking about the terariffing. This is a the average car
is going tolding. Terrors can increase your average car. But
how much heme?
Speaker 8 (07:14):
Just under six thousand dollars. Yeah, so if so I.
Speaker 2 (07:18):
Got to get my daughter a car today, Mike, Just right,
if Donald Trump says, what's six thousand bucks between.
Speaker 3 (07:24):
Friends, like five hundred bucks a month, that's been that
much in red bulls, that's right.
Speaker 8 (07:29):
And this will trickle down to used cars too, so
you have a glut.
Speaker 7 (07:34):
If it becomes a barrier to buy a new car,
then there's gonna be more demand for used cars, so
those prices will go up in accordance with the demand.
Speaker 8 (07:42):
So there's no real getting away from this.
Speaker 7 (07:44):
And it's because so many pieces of the manufacturing process
across the Canadian Mexican US borders, so you'll have the
same metal paying the tariff.
Speaker 4 (07:55):
You know, Mary five time, just take great.
Speaker 3 (07:58):
Always being in your age, in your station wife, always
being in the market for a car. I always be
a market for college, always being a market.
Speaker 2 (08:04):
For I know, I'm coming. Another daughter just turns six,
younger daughter just turned sixteen.
Speaker 4 (08:10):
My older daughters, yes, that makes sense.
Speaker 2 (08:13):
We are old, I know.
Speaker 4 (08:14):
I remember these kids were like eight none.
Speaker 2 (08:16):
I know. And then this my older daughter is going
up to college. Her car is old. I'm like, I'm
in the market for one or two more cars. So
I'm going to shop after this show, forget it before.
Speaker 3 (08:28):
Yeah, how is any of this even affordable? Honestly, how
is this even affordable to me?
Speaker 4 (08:34):
Goose?
Speaker 8 (08:35):
Yeah, I mean there aren't.
Speaker 7 (08:37):
There aren't many solutions for like we were saying in
a show last week, you know, the the median consumer,
of the median car buyer. But some of the things
you should be doing if you need to keep your
budget tight is make sure that you're measuring how much
car you're buying in proportion to your income. So try
and keep your monthly payment or yeah, your monthly payment
(09:00):
at you know, ten to fifteen percent of your income.
That's a big constraint for a lot of people. I
understand leasing cheaper than buying. Maybe explore that as an option.
A big thing that's very easy to do. Make sure
you're paying twice every two weeks, buy weekly.
Speaker 8 (09:18):
Instead of monthly.
Speaker 7 (09:19):
You have an extra payment in there because there's more
weeks than months in proportion, and you also save on
interest with the interest schedules. So paying bi weekly annoying
for some people, but can really help a little bit.
And then a lot of upgrades are flashy and not needed.
They're nice to haves, not need to haves. I understand this.
I actually kind of disagree with this one I read
(09:40):
about it. I think some are fairly essential to car
companies will say, oh, you know breaks add on, you
know some things like that.
Speaker 4 (09:49):
Howie, what's the repo market like?
Speaker 1 (09:53):
If so many people out there are delinquent on their
loan payments or car payments.
Speaker 4 (09:59):
A lot of this picking up cars.
Speaker 1 (10:00):
Yeah, they're picking up cars because I'm thinking, go to
a police auction if you want to get a good car.
Speaker 4 (10:06):
Yeah, but then you pay. But here's here's the thing though,
and how are you then you pay cash?
Speaker 3 (10:09):
I used to I want to cash, but why use
your own cash? You use other people's money. During the
low interest rate periods, okay, and the low interest rate
periods were were interesting because keep in mind, we were
talking about two percent for a while.
Speaker 4 (10:23):
Carlows are now, you know, in the tens and elevens, right,
So how he is?
Speaker 3 (10:26):
So it's you know, would you suggest see, I think
it's okay to have a little bit of debt in
a car because you have because they're so expensive, you
have to. So let's continue this conversation. But I'll tell
you what. How he thanks for the bad news and
Mary's leaving early again.
Speaker 1 (10:41):
He is our market analyst, the beautiful handsome how we
fund move back on later in the show, and don't
you go anywhere? Are you peep once more to come
with the big miss show?
Speaker 4 (10:53):
Keep it here all right? Hope you guys are having
a great day.
Speaker 1 (11:02):
We certainly are because you are along for the ride
with us along with the dtt T Trader trio here
at tomorrow.
Speaker 4 (11:11):
It's costin herber Gobbin.
Speaker 1 (11:12):
Our executive producer is Greg Toddrov and of course Sully and.
Speaker 4 (11:16):
We are brought to you by Prudential. Let Prudential be
r Rock for Retirement.
Speaker 3 (11:19):
Also brought to you by Bayer Advancement, Better Science, better Results.
Speaker 4 (11:23):
It's not the kind you take, Mike, it's the fertilized.
I learned that the hard way. I know you did
start abucks coffee.
Speaker 3 (11:29):
I'm popped up on some right now after I snorted
my add medicase Bloomin brands. You may have heard some
of the restaurants out back Steakhouse, and they're authentic Austilian food,
including He's bloomin onion.
Speaker 4 (11:42):
Which grows in the sides of the roads in Crazy.
That's one of fort Tater guitars, furs guitars, couse.
Speaker 3 (11:47):
I am so excited that this next guest is on.
David Dodd was a regular guest a number of years ago.
Just a really great individual. Get to see him in
person and via zoom. He is the chairman and CEO
of a company called Geovac's Lab. There are political days
biotechnology company developing vaccines for some of the world's most
threatening infectious diseases. However, they pivoted a number of ways
(12:10):
in serving humanity through innovations and immunology. And I just
reached out to him and said, listen, I got a
couple of emails asking whatever happened as YOVACSI you guys
used to have them on the air all the time.
Speaker 4 (12:17):
I reached out to David, we got to talk and
guess who we have once again on our studios. David,
Great to see you man.
Speaker 8 (12:23):
How are you doing?
Speaker 9 (12:25):
Good?
Speaker 8 (12:25):
Glad to be here.
Speaker 4 (12:26):
Thank you?
Speaker 10 (12:27):
Hey, can you get give us a catch up twofold,
catch us up on where you guys are at, but
maybe right before that, tell us a little bit of
what you guys are actually concentrary on what are you
guys doing these days.
Speaker 9 (12:38):
Sure, we're concentrating on three key proverbs and it's very simple.
That's what we spend, That's what our balance sheet is
focused on. That's what I'm focused on. One is the
next generation COVID nineteen vaccine. The big news there.
Speaker 4 (12:53):
Last June, we.
Speaker 9 (12:54):
Were awarded approximately four hundred billion dollars from the federal
government in support of our vaccine in a major trial
that will compare it to the MODERNA vaccine, So it's
an efficacy trial. It's very exciting. We have other programs underway. Secondly,
we now have which we didn't have the last time
we talked. We have a product of vaccine advancing on
(13:14):
an expedited process that will be the first US based
supplied impos or monkey pocks vaccine, which also is used
to prevent smallpox. Right now, there's a single supplier worldwide
we're going to end that monopoly and have an on
showing basically a US based supplier is going to be
out there that's advancing very rapidly. And then thirdly, pardon me,
(13:40):
thirdly our cancer therapy CADEPT, and we announced last summer
that we are going forward with a phase two clinical
trial and first recurrent head and neck cancer patients utilizing
our GODEPT and combined with what's known as a checkpoint
inhibit or something such as k truda, where we think
(14:00):
it'll show some significant value for people who are having
first recurrent head and neck cancer patients. So those are
the three programs that we have. So we're doing a lot,
accelerating a lot, moving as quickly as we can.
Speaker 3 (14:14):
You know, David at you you bring up a key
point here talking about moving a sickly as can. You
guys are moving at the speed of light. When we
first talked to you, you had a lot of you
had a lot of good traction on on your on
your original therapy here. But what got you, guys the
sort of the catalyst to go in multiple directions because
(14:34):
you because you predicted that this was going to happen,
and sure enough you're doing it. Now, was there a
tipping point that got you guys in the right direction there?
Speaker 8 (14:40):
Well, there were a couple of my believe.
Speaker 9 (14:43):
In twenty twenty two, we had the monkey pox out
break because it was known now it's known as IMPOCS.
But we want we were apparently offending monkeys worldwide.
Speaker 6 (14:52):
So we had to change the things.
Speaker 9 (14:55):
Who said we're offending monkeys, call it impoc Yeah, it's
same virus.
Speaker 4 (15:01):
But we just we don't want to shave up up
the monkeys.
Speaker 9 (15:04):
And so that broke out in twenty twenty two in
the spring. It again broke out this past August. In fact,
just recently February twenty second, who issued their third declaration
of a public health global health emergency in only six months.
That's almost unprecedented that WHO would take such a strong stance.
(15:25):
We realized in twenty twenty two that there was a
single player worldwide making hundreds of millions of dollars in
sales because they were the only ones supplying the product.
And yet we had the same product essentially on the
shelf here. So we acquired the rights from NIH and
we now are about to start yet this year, our
own clinical study reviling the product basically putting into the
(15:48):
little glass vial so you can take it out with syringe.
That's underway as we speak, and so yet this year
that'll go into its clinical trial, so we're very excited
about that. The other thing was twenty twenty three, the
White House came out with a program called Project next Gen,
recognizing that those first generation COVID nineteen vaccines had some
(16:09):
very significant limitations. They had to continuously be reconfigured every
time there's a new strain or varying. They also don't
last long, as we all had talked about in the past,
people were having to get another shot every three to
six months. And then finally, populations who have certain blood
cancers or kidney disease, basically their bodies are compromised from
(16:32):
the immune side. The current the first generation vaccines don't
work for them. Our vaccine was constructed to work specifically
for those people, and that led to the award that
we had house last June of approximately four hundred million
dollars for a major trial, a ten thousand patient trial,
half of whom will be receiving our vaccine, the other
(16:52):
half the Maderna vaccine. So it really pushed things forward
and then we ended up completing what we were doing
with good depth in our solid tumor therapy, and we
realized that, you know, there's a real need in first
recurrent head and neck cancer patients, and we can actually
improve the type of products that an updivo or that
(17:14):
A K true they called checkpoint inhibitors. If you combine
those with our product, you'll get a much better performance
of those products. And so that's what led us into
this focus on these three programs. In essence narrowed it away,
so we're not doing anything at this time on the
Ebola's or the marl Bergs, basically the hemorrhagic fever viruses.
(17:34):
Set those aside, set zeca virus aside, and focused and
then we applied our balance sheet to speed things up.
Speaker 8 (17:41):
So that's what we've done.
Speaker 1 (17:42):
David Dodd, Chairman, CEO Geovac's Labs Incorporated.
Speaker 4 (17:46):
The ticker symbol is g o v X.
Speaker 1 (17:48):
David, being part monkey, I thank you for a now
cahol of it improduct. If we, in all seriousness, if
we were to have another massive outbreak like covid H,
how is Geovacs doing? Are we as a nation, as
a world, are we kind of neck and neck with
the new viruses. Are we getting out ahead of them?
Speaker 9 (18:08):
Well, it's hard to predict, because you can't predict a
new virus until it emerges.
Speaker 6 (18:13):
I mean that's the challenge.
Speaker 9 (18:14):
Sure, what you can put in place is pandemic preparedness
as it's referred to in the industry and government and
onledge and I think we're doing a much better job
regardless of the administration in place. I would say that
the new administration is experienced. They were the ones that
led Operation Warp Speed. This Project next Gen is the
(18:34):
follow on to that. I think they have come in
very well equipped and with readiness to be better prepared,
be more flexible. We're looking at a new manufacturing process
that will increase the yield by tenfold of what you
normally produce out of certain fact infectious disease vaccines. It
(18:56):
will improve it will accelerate how many batches you can
do in a certain time period, so that's like a
compounding feature, and most importantly, we estimate that it'll reduce
the cost five fold, which means we can then make
sure that it's getting to places in Africa and other
places that literally in some cases have simply not been
(19:16):
able to afford to be able to utilize some of
the vaccines. So they were at the end of the
line with COVID nineteen. They should be at the front
of the line with IMPOS, but they're still at the
end of the line there. So we're working very closely
with Africa also in that regard. So I think that
the industry, public health in general is better prepared now
(19:36):
than certainly everyone was in twenty twenty. New technologies, new
manufacturing processes I mentioned are coming forward, So I think
now it's a major focus today. You've got to do
a better job and don't just kick the can until
the next pandemic.
Speaker 1 (19:51):
We amen, I'm in yeah, GOVX says the techer symbol
Geovax Labs Incorporated. He's their chairman and CEO, Mister David Dodd.
Please do not be such a stranger.
Speaker 4 (20:00):
David Dave. We'll see you again.
Speaker 1 (20:04):
In over one hundred and seventy five countries and all
the ships and sea on the American Forces network. It
is the big BI show, those three guys playing on
that stage. Just to day Trader Trio best in the
business US here at tomorrow. I'm the jury still out.
Costa Maryburg Godwin, Greg Potterov's our executive.
Speaker 3 (20:27):
Producer and of course, so I had a great call
this morning with Shane Shafer and his team because we
are doing as we are, as we are known to do,
not very often, but we get to do these a
couple times a year as a a bus you mentory
on ADHD and when the network sees some of the
(20:47):
work we do here on Big BI Show in terms
of when we do the suicide ideation or we did
the sleep apnea or even a liver cancer, they heard
Shane and said, you know, because it's it's more of
a it's more of a uh public service to hear about.
Speaker 4 (21:02):
Some of this stuff.
Speaker 3 (21:03):
And UH Devon and UH and and company, we're on
that call this morning to talk about sort of the
uh sort of the narrative. So you're gonna see this
here on biz TV here. I think it will take
us about eight nine weeks to produce the thing, maybe
less depending if if we you know, put put Devon
in a hermetically sealed send him out.
Speaker 4 (21:26):
To shoot, put him in.
Speaker 3 (21:27):
He came of his team and I guess, but it
was it was really encouraging it. And and the more
I hear the story, and Shane can Shane Shaffer her
CEO of Singulate, chairman and CEO of Singulate.
Speaker 4 (21:36):
By the way, ticker singles C I, N G. And
you go to singulate dot.
Speaker 3 (21:40):
Com once you agree uh, And Shane, I bet you
don't get tired of saying this is about the inavailability
of options that you guys are resolving in terms of ADHD,
and think of it this way. Most people align ADHD
with children, but that's not the problem, you know, So
(22:01):
the same taking I thought that was this this morning,
even though we're planning on doing, on creating something, it's
just illuminating to me. And how much you get to
talk about this and I get and I bet the
light bulb goes on every time you talk to somebody
about the fact that this ADAC issue is robbing families
of their moms and dads, it's robbing productivity, and there's
(22:21):
a solution here.
Speaker 4 (22:22):
I'll let you take it from there. I'll be good
stuff this morning.
Speaker 11 (22:24):
By the way, good to see you too, A Hello team.
Speaker 6 (22:27):
I'm wearing my Raider black.
Speaker 4 (22:31):
And Mike's wearing a little casey red. I always knew
you'd come around.
Speaker 6 (22:36):
Take me to a game, and I'll go anew there.
Speaker 3 (22:39):
You know we're doing that this year. We are all
going to go to Las Vegas. But I'll be wearing
my home's jersey right with you, buddy, all right, So.
Speaker 11 (22:50):
Take you away A good point solely, and I think
you know, funny thing is is that there's so many
treatment options out there in terms of different medications that
have been approved, but there's still not a single treatment
option available yet that is going to give a patient
the ability to overcome all these these unmet needs. And
it just it starts with one simple phrase. We want
a product that lasts a patient's entire active day and
(23:14):
active day. And that's the key point, is I mean,
you want this medication to start right away last long enough.
And now we walk into some more troubles side effects
from getting medications that are too much, too many milligrams,
too low of a milligram dose, products that don't last
long enough, which is all of them, products that have
this crash and rebound, which is a side effect of
coming off the medications. You have the need to take
(23:36):
booster doses, which sixty percent of patients take every day
in a twenty three billion dollar market by the way,
and no one solved this problem. Singulate has a solution.
And then with those booster doses, those are your short
acting stimulants. That's where ninety nine percent of the abuse
and diversion exists. That's the college campus problem. That's the
adult issue. That's you know, not so much the children,
but that's the adult problem. You walk around with these
(23:58):
class two stimulants in your post and you know that's
where problems exist. You know, you crack it, you crush it,
you store it, you share it. What we've done is
we've created a product where you take one tablet right
away when you wake up. We start working within thirty minutes.
We last your entire active day. We get you from
home to homework, from breakfast to dinner, from revelry to taps.
(24:18):
We take you through your active day. And in doing
so too, we want to lower the side effect and
the tolerability burden. We've done that as well. Our data
looks tremendous. So we're really excited about number one, the
opportunity to bring this to patients and payers and providers
and payers are looking forward to this as well, which
is interesting because they know the problems. They know the
problems with these short acting stimulants and they want their
(24:41):
rebates as well. And we're going to be a branded
product that's poised to really be the dominant force in
ADHD moving forward, because this is the solution patients and
providers have not been just.
Speaker 6 (24:51):
Wanting, but been begging for.
Speaker 11 (24:53):
And we do it by giving three doses at the
right time, at the right place, in the right ratio
and in the right stuff of release pulse, sustained release
pulse thirty five, forty five twenty at zero three and
seven hours. No one's ever done that before. We've done
it because well because frankly I worked at nov Artists
and created some failures. They were good products, but they
(25:13):
didn't solve the problem. So we brought in the top
experts and they developed this product for us. We listened
to them and that's where Singulate's product comes from, and
we're really poised to be the leading product in ADHD
as soon as this product gets approved.
Speaker 4 (25:26):
Shane Schaefer is the chairman and CEO of Singular. Their
ticker symbol is ci n G Hey.
Speaker 2 (25:34):
She and I wanted to ask you a question about
the stigma as it relates to ADHD and taking medication
because I think I've told you in the past that
my daughter I didn't know that, you know, the way
her behaviors were related to ADHD, and I had a
stigma about it completely. And when I heard that she
(25:54):
was a textbook case, I thought, no, you know, I
was thinking, number one, she's not the little boy in
the corner with the fidget spinner. And number two also,
I was nervous kind of what you alluded to with
ADHD leads or the medication can lead to abuse and
all the other things. So right, are you seeing a
change in that stigma? And how do you or does
your company help kind of educate the population about it?
Speaker 11 (26:18):
You know, there have been you know, we get a
walk on the shoulders of giants, as we say from
time to time. And I think companies like Shire and
Novartists and Jay and J and you know, some of
those folks did a great job of educating, you know,
folks and getting people to understand that ADHD is a
neuro biological disorder. It is the most genetic of any
mental health disorder that exists. So odds are folks if
(26:40):
you're a parent listening to this and your child as
ADHD one of you. You are one of the people
that helped create this child. It probably has ADHD as well.
It's a very highly genetic disorder. You know, you look
back in the eighties, depression had a stigma around it.
We pushed through that it's a very real issue. Same
thing with ADHD, and I think it's very well accepted
that it is a real disorder. However, there is still
(27:02):
a lot of misinformation out there. It's always much more
glamorous to point out the one person who had trouble
on a medication or did something poor while they were
on a medication. The reality is this, there's twenty two
million Americans that have clinical ADHD in this country now.
Only fifty six percent of them are being treated with medications.
(27:24):
So you know, over prescribing and overuse of these medications
is not the issue. Are there times that is absolutely
to your point about abuse and diversion? Yes, that's wrong.
So let's just take that tablet, that little a short
acting booster.
Speaker 6 (27:35):
Let's get rid of it. We fixed it that it's
in our tablet.
Speaker 4 (27:39):
So I think the stigma is.
Speaker 11 (27:40):
Largely being overdone, overdone, but you know, it's glamorous. That'll
catch a headlined versus patient effectively treated. That never really
gets too exciting. The reality is this ADHD is real.
Patients have a lower, shorter lifespan, they have more accidents,
they have less job security, they have twice the rate
of a ready high rate of divorce, they have a
(28:02):
double the rate of incarceration. These are real problems that
affect society. And look, I am all for you know,
good behavioral therapy as adjunctive therapy with ADHD.
Speaker 4 (28:14):
We need that and we'll do that.
Speaker 11 (28:15):
But at the end of the day, this class of medications,
the stimulant class, is the most effective and safe medications
out there.
Speaker 6 (28:20):
We're making it better at Singular.
Speaker 3 (28:22):
Is there compassionate care opportunities for a drug like this?
Because there's at least six people in our studio that
I find it would be compassionate for you to give
Mary some.
Speaker 4 (28:32):
Can forgive me some. But the point is, honestly though,
is there a compassionate care element to something like this? Oh?
Speaker 11 (28:38):
Absolutely, I mean there's there's a look your typical approval process.
We plan to file our new drug application with the
agency in the late July early August timeframe. The review
period as anywhere from six to ten months, depending upon
which review Singulate receives for its lead asset thirteen oh
one will depend on We'll depend on some factors, but
then also result in some ability for the company to
(29:01):
potentially provide the product in the compassionate manner sooner than later.
Regardless as the product. When the product gets approved, we
will be providing compassionate use.
Speaker 6 (29:11):
Absolutely.
Speaker 11 (29:12):
We'll have you know, the typical coupons and the long
term co payment cards, and we'll have we'll have tools
available to make sure patients that no matter what their
health plan is, no matter what their socioeconomic status is,
they'll have the ability to access these products.
Speaker 3 (29:27):
Marry this time next year, we're spending a lot of
time in case in the Midwest.
Speaker 4 (29:31):
Hey. Last of all, let's talk about this press release.
Speaker 3 (29:33):
It came out last week reporting the safety results for
your final Phase three trials UH for for the for
the thirteen oh one.
Speaker 4 (29:39):
I'll tell you what this is. This is I'll let
you take it from there. You're beating your answering.
Speaker 11 (29:44):
The key to key takeaway is number one. This product
is once again demonstrated, as it has now in nine
human trials, that we have delivered a and created a
product that has an excellent safety and tolerability profile. In
our fast Fed study, which was the highest dose fifty milligrams,
that's equivalent to one hundred milligrams of riddlin, so it'll
be the highest available commercial dose ever. We had tremendously
(30:09):
positive data in terms of the fact that patients weren't
jumping out of the study. It's a very high dose
fifty milligrams, so we're really encouraged. Again, you know, nine
straight trials of lower or no side effects versus other
treatments out there, So look, the data has looked incredible.
We're excited to get the fast Fed pharmaco kinetic data
(30:31):
out in the next month. We did this already at
a middle dose of twenty five and we demonstrated that
this product can be taken with without food. So at
the end of the day, what we want to be
able to do is tell physicians that this product is
approved for patients six and older, take it with without food,
and enjoy an.
Speaker 6 (30:46):
Entire active day of solid ADHD.
Speaker 1 (30:48):
Efficacy Change Shaper Chairman CEO single it take the symbols
ci NG cannot wait for the bijumentary, Can I wait.
Speaker 4 (30:57):
For this and that's the return of the big this
show with us. We're gonna get more of it right
after this.
Speaker 5 (31:07):
Mhm.
Speaker 1 (31:14):
Once you get a big old hobbie to you, as
we like to shay here in them these parks.
Speaker 4 (31:18):
It's the big, big show.
Speaker 2 (31:19):
Nobody says that.
Speaker 4 (31:22):
We're inside.
Speaker 2 (31:25):
This is why he works.
Speaker 4 (31:29):
Because he knows if he was ever booted, it's over.
Speaker 1 (31:33):
It's you know, him saddle up to the bar, y'all costa,
Mary Off and Sully.
Speaker 4 (31:40):
You just harpooned me. No one ever says.
Speaker 3 (31:43):
That's right for yourself as a harpoontable.
Speaker 4 (31:48):
Yeah, you know, it was a it was a jungle,
it was a blow dart.
Speaker 1 (31:55):
Joining us right now is John Evanderbolsen, a senior life
science analyst for a small cap research and unboxing biotech.
It's got his thumb on the pulse of everything file
Tech quickly become one of our favorite guests.
Speaker 4 (32:09):
Mister v how are you doing great? Hey? What's what's
a digital twin other than me and Mike? Yeah?
Speaker 12 (32:18):
Well, you know everyone's heard of AI, and a digital
quinn is one way that AI is able to represent itself. So,
for example, a company may want to run a clinical trial,
but clinical trials are expensive. You get to find people
to populate it. So what they can do is recreate
the the responses of a patient in a digital twin
(32:39):
and run the trial on that and then save a
lot of money. They still have to do it in
people eventually, but it helps a lot of the early
stage research. And you know, big names like Buyer and
Santa Fe are both, you know, among many others. Actually,
Mark Germany's another one. They're all they're all using digital
twins to get things started in their clinical trial.
Speaker 4 (33:00):
John, is that all AI generated? When you were talking
those terms.
Speaker 6 (33:04):
Yeah, yeah, I'd say AI is what what is behind it?
Speaker 12 (33:07):
I mean digital twins have been around for a long time,
you know, I think AI kind of as we you know,
think about chat, GPT and things like that. It's it's
been around what like two years now, right, Yeah, but
digital twins have been around quite a bit longer.
Speaker 6 (33:20):
But you know they're becoming a lot more sophisticated now.
Speaker 12 (33:23):
In the early stage, you know, they could only look
at a few a few variables, but now they're pretty
good at replicating the way a patient would would respond.
Speaker 6 (33:31):
So there's there were a couple of a couple of studies.
Speaker 12 (33:34):
There was let me look right here, there was one
for asthma that Santafi did and Buyer did one in diabetes,
and the latter one they were actually to able to
estimate what glucose levels would do with certain drugs, so
they could see how they worked, and then you know,
they could pick the right one to actually go into
clinical trials and use on patients. So you know, they
saved a lot of money, saved a lot of time.
Speaker 6 (33:55):
In doing this.
Speaker 3 (33:56):
I always sort of and I don't know, this is
a pretty and alley trade to minimize when bullets are
whizzing overhead. I tend to be a glass half full
sort of person and trust the process. On the other hand,
Mary and I were living two separate.
Speaker 4 (34:11):
Lives during COVID.
Speaker 3 (34:12):
I was on my bicycle outside finding every bar I
could that was serving beer, even.
Speaker 4 (34:16):
It was closed. You because your kids are in school.
Speaker 3 (34:22):
Because I had parents, i'd have at least be a
little less sociopathic when I came to the pandemic, but
I just wasn't scared of it. I think the reason
why I wasn't scared of the pandemic was because when
my parents texted me, say, hey, bab can you run
to Tater Joe's for us and get his two rolls
of toilet paper, some of that sugar free chocolate, and
three cases of two buck chuck.
Speaker 4 (34:43):
I'm not kidding.
Speaker 3 (34:44):
I have the text message my mom asked for three
cases of wine during COVID. Okay, I'm not You, on
the other hand, were very concerned, as were most of
the people. The reason I'm asking this is there's multiple
infectious disease outbreaks right now. Closest to home is the
measles right here in Texas and New Mexico. In Texas
and New Mexic Co. But but we've got to talk
about that because is biotech doing a good job now
post COVID of getting uh getting us ahead of the
(35:08):
curve here?
Speaker 4 (35:10):
Well, you know, it.
Speaker 12 (35:10):
Looks like a lot of the funding for some of
those programs that were able to do early responses is
kind of dissipating a little bit.
Speaker 6 (35:17):
But yeah, I mean it's it's kind of it's kind
of scary. I guess you know. I was just getting
updated on the numbers.
Speaker 12 (35:23):
It looks like there's about two hundred cases now in Texas,
two hundred and fifty around the United States.
Speaker 6 (35:28):
That are going on. But but that's not it.
Speaker 12 (35:30):
There's actually there's in a bowl about breaking the congo.
And then there's the Marlburg virus. This is similarly kind
of bad for you. And then and then did you
hear about Gene Hackman. I don't know if you've heard
about him.
Speaker 4 (35:42):
Yeah, so so so what so his wife passed away
from a rat infestation.
Speaker 3 (35:47):
He has Alzheimer's by the way, poor guy, yea, And
apparently he didn't know his way passed. He lived in
the home for an extra week himself, and then he
caught it and died, and of course they discovered there.
Speaker 4 (35:58):
It was this horrific scene.
Speaker 3 (36:00):
And I really wish the PR firms did a better
job of this because I don't want to remember Gene
Hackman having old timer dying with his wife ten days later,
you know, and then winning other ten days is decomposed.
Bodies are found and so helping them narrative here, But
but you know, continue on because it's this is not
as far away as we think it is sometimes, right, I.
Speaker 12 (36:19):
Mean, infectious diseases all around us, and uh, you know,
vaccines have been one of the ways we fought it. Now,
now that's the thing that the hantavirus that his wife
caught and potentially he caught as well. That I don't
I don't think there's a vaccine for that. It's pretty rare.
But still, you know, you gotta be you gotta be
careful and and not go sniffing around where you shouldn't.
Speaker 1 (36:40):
Got John, is is uh that wascally monkey pot stuff
still around.
Speaker 12 (36:45):
Or or you know, yeah, I think that there was
another outbreak of that also in Africa. Now there's sweet
different kinds of monkey pops. Actually, there was one that
we had here a couple of years ago, you may remember, Yeah,
that was that was not so easily transmissible. The one
right now that's moving around Africa is actually a little
bit more transmissible. So you know, the thing that I'm
(37:07):
always worried about is, you know, we're just an airplane
flight away from some of these things, and you know
we all live near international airports, so you know, launching
the markets go down, right, you know.
Speaker 3 (37:20):
The instanct part of this is that, you know, we
hear just a few weeks ago that likely this COVID
outbreak was from that lab in China, so on and
so forth.
Speaker 4 (37:31):
If something like this happened again.
Speaker 3 (37:32):
And the reason I'm asking you, John is because you're
in the biotech space and you're you're do you think
that that our reaction time would be different?
Speaker 1 (37:40):
Now?
Speaker 4 (37:40):
Are those biotech companies have they changed anything?
Speaker 6 (37:42):
Are they not?
Speaker 4 (37:43):
That they have responsibility to? But are they at the
ready now for something like this?
Speaker 3 (37:46):
You know, in the wake of in the wake of
meathles and that and the and and empos and all
that stuff, we.
Speaker 12 (37:52):
Have more tools. I mean, there is a there is
a vaccine for empos. Uh, it's like it's it's it's
a pox virus vaccine.
Speaker 4 (37:59):
That we're for.
Speaker 12 (38:00):
I think, uh, chicken pox or it works for another pox.
Speaker 6 (38:06):
Virus.
Speaker 12 (38:07):
But you know, I think with the with what was
what Pfizer did with its vaccine, and that was pretty amazing.
I mean, what was it fourteen months or something from
beginning to having a vaccine. You know, I think we've
learned a lot. So yeah, I think if we had
an outbreak, we could respond much faster. But still, you know,
I couldn't see it happening much faster than a year.
Speaker 1 (38:26):
Uh.
Speaker 6 (38:27):
And it costs, you know, I mean, it costs a
lot billions to do so it's we.
Speaker 3 (38:32):
Have cheap hey less than thirty seconds. John, sounds like
the capitol markets are opening up for biotech. Is that
what I'm hearing for the second quarner.
Speaker 12 (38:39):
Here, Yeah, well, you know, I would say the markets
are down pretty sharply today, but I took a look
at the healthcare space and it's actually up if you
look at the sub industries, and you know, I advise
the viewers to do this to kind of see how
the charts look over the last three months for the
SMP versus the healthcare sub indisease.
Speaker 6 (38:57):
But biotech and.
Speaker 12 (38:59):
Pharmacy uticles both are half pretty nice looking charts over
the last three months, especially the last several weeks.
Speaker 6 (39:05):
So you know, maybe it's time to take a look
for some sector rotation.
Speaker 1 (39:08):
Right John Vanden Molson, Senior Life Science Analysts, Sachs Small
Cap Research and Unboxing Biotech your go to for measles
and monkey Fox. John always appreciate the visit that is
going to do it for this edition of The Big
Bis Show.