Questions for Tim

This forum is to discuss general things concerning TSOI.
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TimGDixon
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Re: Questions for Tim

Post by TimGDixon »

I'll try and wrap up curncman, cody, and tsoi-ry in one :lol:

What can i really say; we are not really like any other biotechs for the most part even though we live in a premiere biotech area and collaborate with the very best minds we can find. Any number of our inventions can bring 10's to 100's of millions to billions depending on "proof". Proof is the key and you see us doing lots of experiments and reporting on the successes but we have our failures too like many companies - perhaps the difference is the volume of IP we hold - no one would buy it all but they could buy pieces now couldn't they - i mean thats the idea right - we off one piece of human proofed IP and we can self-fund everything. Many companies have one doo-dah and if it fails they are toast - what you see presented is everything that didn't fail thus far - we don't file patents on failed experiments and we don't file unless we think we can own the space. This is why there are so many stemvacs related patents. We have to own the space and we have to lay enough land mines that any invaders have to seek our permission to advance their cause which may need our IP.

Things that are coming out now are experiments and such that we commissioned a year ago and the list is long... so if pajama boi's are still crying let em cry more because we have lots of stuff coming down the pike you haven't even hard about yet... oh a week in the woods cleared the noggin and i'm ready to sizzle some brain cells.
TSOI_Ry wrote: Wed Jun 02, 2021 11:39 am Then, maybe a better question is, which wealthy influential Pharmaceutical firm will seek to profit from groundbreaking cellular regeneration?? And how long will the line be? And who’s up first?

Biotech’s research and develop, Big Pharma acquires (via licensing/partnership/buy out etc), sells, distributes.

But first, proof. When the proof is empirical, the rest will undoubtedly fall into place. With efficacy rates of 91% (JadiCell/lung/Florida/2020 and 100% (StemVacs 1st Gen/2015-18/MX/Stage 4 cancer) I’d wager there are eyes on these coming ph3 FDA trials. But we aren’t RGBP. There’s no reason to cut quick low ball deals.
There in, I believe, is the difference. We’re positioned differently; smartly. Nearly 50 patents. Firing on all cylinders. Unfortunately, all we can do while we wait is speculate about how the market will react when the “big news” drops. But that’s really just the beginning. There’s still a well thought out road to be traveled ahead. Think EPS. We don’t control pps until then. And I’d add, what political animal would want his/her name aside a “cure for lung injury/ Covid-19 patients”. Or a “cure for Cancer”?
All in due time my friend. Your point is a good one, it’s a bit of a rigged game, but how many horse and buggy’s do you see on the road? Change is coming. 🤓🍻
dneedle280
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Joined: Fri Feb 26, 2021 7:45 pm

Re: Questions for Tim

Post by dneedle280 »

Oh my that's a long drive. The 3 hour drive to Ocean city MD for is a long drive. Can't imagine a 20 hour drive. The most I have driven at one time was 17 hours from Baltimore to Paducah Kentucky.
sego1357
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Re: Questions for Tim

Post by sego1357 »

Tim

I’m confused on the BIG news update, is it directly related to the 7 rounds of FDA questions you completed on 6/4/21, or are these 2 separate developments?

Thanks!
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TimGDixon
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Re: Questions for Tim

Post by TimGDixon »

yes the questions have to do with BIG news yet to come.

And to clarify we are on our 2nd round of question (awaiting 3rd round) with FDA on IND 27377 for CTE using same JadiCell.
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TimGDixon
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Re: Questions for Tim

Post by TimGDixon »

Let's hear it for Paducah Kentucky - i think thats where Browne Badgett came from, he was big coal guy some time back... its 22hrs each way so it was 44hrs driving total this trip lol
dneedle280 wrote: Sat Jun 05, 2021 9:03 am Oh my that's a long drive. The 3 hour drive to Ocean city MD for is a long drive. Can't imagine a 20 hour drive. The most I have driven at one time was 17 hours from Baltimore to Paducah Kentucky.
sego1357
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Re: Questions for Tim

Post by sego1357 »

Thank u for the quick answer & clarification!
Codycrusher
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Re: Questions for Tim

Post by Codycrusher »

This is a fact and what I think from the overall view of things on the patent perspective Tim.
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Codycrusher
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Re: Questions for Tim

Post by Codycrusher »

So Tim, on a side note this company, separate company was granted FAST TRACK to get this marketer, straight to phase 3 pretty much.
https://ca.finance.yahoo.com/news/vbi-v ... 00648.html
Now my question is, do you think we could get what you’d call as Fast track for Stemcells or whatever, just wondering because there is a lot of people in need of the treatments from Jadicell and stemcell specifically.
Stemcells for the reason of covid curing.
Jamesy
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Joined: Wed Feb 24, 2021 2:06 pm

Re: Questions for Tim

Post by Jamesy »

Hey Tim,

Are you familiar with the company "NeuroRx" trading as NRXP? Much like TSOI, they are currently trying to address patients that have suffered respiratory illness as a result of COVID-19. Specifically with their drug Zyesami, in which they have completed various phase 2 trials and are applying for emergency use authorization. The therapeutic outcome does not seem as positive as TSOI's JadiCells, but I was hoping to get your opinion on the matter. Is there any worry regarding getting beat to the punch timeline-wise, if their EUA gets approved, despite us appearing to have the clinically superior therapeutic? I hope the FDA allows us to at least get a foothold or foundation in medicine soon so that we aren't beat to the punch per see.

Below is an article for reference with information related to NRXP's Zyesami drug.

https://www.prnewswire.com/news-release ... 57291.html
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TimGDixon
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Re: Questions for Tim

Post by TimGDixon »

It sounds very promising and we certainly need as much potential help for people as can be had is sort of my attitude. We are not threatened by this, as our Phase 1/2a showed an over survival rate of 100% in patients under the age of 85 and 91% in patients over 85. This is superior to the results pasted and highlighted below with ZYESAMI™.

As to EUA of course post IND approval we will look at that but for us first things first is IND approval. That will open every door we need to open.

"In addition to the robust overall significance across all 196 treated patients at all 10 clinical sites, the prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals. In this group, ZYESAMI™ patients had a 71% chance of successful recovery by day 28 vs. 48% in the placebo group (P = .017) and a 75% rate of successful recovery by day 60 vs. 55% in the placebo group (P = .036). Eighty-four percent (84%) of HFNC patients treated at tertiary medical centers with ZYESAMI™ survived to day 60 compared with 60% of those treated with placebo (P = .007)."

Abstract ( https://pubmed.ncbi.nlm.nih.gov/33400390/ )
"Acute respiratory distress syndrome (ARDS) in COVID-19 is associated with high mortality. Mesenchymal stem cells are known to exert immunomodulatory and anti-inflammatory effects and could yield beneficial effects in COVID-19 ARDS. The objective of this study was to determine safety and explore efficacy of umbilical cord mesenchymal stem cell (UC-MSC) infusions in subjects with COVID-19 ARDS. A double-blind, phase 1/2a, randomized, controlled trial was performed. Randomization and stratification by ARDS severity was used to foster balance among groups. All subjects were analyzed under intention to treat design. Twenty-four subjects were randomized 1:1 to either UC-MSC treatment (n = 12) or the control group (n = 12). Subjects in the UC-MSC treatment group received two intravenous infusions (at day 0 and 3) of 100 ± 20 × 106 UC-MSCs; controls received two infusions of vehicle solution. Both groups received best standard of care. Primary endpoint was safety (adverse events [AEs]) within 6 hours; cardiac arrest or death within 24 hours postinfusion). Secondary endpoints included patient survival at 31 days after the first infusion and time to recovery. No difference was observed between groups in infusion-associated AEs. No serious adverse events (SAEs) were observed related to UC-MSC infusions. UC-MSC infusions in COVID-19 ARDS were found to be safe. Inflammatory cytokines were significantly decreased in UC-MSC-treated subjects at day 6. Treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), SAE-free survival (P = .008), and time to recovery (P = .03). UC-MSC infusions are safe and could be beneficial in treating subjects with COVID-19 ARDS."
Jamesy wrote: Wed Jun 09, 2021 9:21 am Hey Tim,

Are you familiar with the company "NeuroRx" trading as NRXP? Much like TSOI, they are currently trying to address patients that have suffered respiratory illness as a result of COVID-19. Specifically with their drug Zyesami, in which they have completed various phase 2 trials and are applying for emergency use authorization. The therapeutic outcome does not seem as positive as TSOI's JadiCells, but I was hoping to get your opinion on the matter. Is there any worry regarding getting beat to the punch timeline-wise, if their EUA gets approved, despite us appearing to have the clinically superior therapeutic? I hope the FDA allows us to at least get a foothold or foundation in medicine soon so that we aren't beat to the punch per see.

Below is an article for reference with information related to NRXP's Zyesami drug.

https://www.prnewswire.com/news-release ... 57291.html
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