Questions for Tim

This forum is to discuss general things concerning TSOI.
trader32176
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Questions for Tim

Post by trader32176 »

Questions for Tim

Please use this place to ask your general questions to Tim .
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This topic thread is for asking general questions to Tim .

curncman
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Joined: Fri Jun 26, 2020 8:27 am

Re: Questions for Tim

Post by curncman »

Hi Tim, I came across this article on Yahoo FDA approves Amgen drug for lung cancer with specific mutation

https://www.yahoo.com/news/fda-approves ... 07760.html

Deena Beasley
Fri, May 28, 2021, 12:59 PM
By Deena Beasley

(Reuters) -The U.S. Food and Drug Administration on Friday approved an Amgen Inc drug for lung cancer patients with a specific mutation in a gene known as KRAS whose disease has worsened after treatment with chemotherapy or other medicines.

The drug, sotorasib, which will be sold under the brand name Lumakras, shrank tumors with the KRAS mutation in around 36% of patients in clinical trials.

The medication is designed to target a gene mutation known as KRAS G12C that occurs in about 13% of non-small cell lung cancers (NSCLC), the most common type of lung cancer.
Amgen said the drug will have U.S. list price of $17,900 per month. Wall Street analysts, on average, expect 2022 sales of $240 million, according to Refinitiv data.


When u have free time I was wondering if you throw some light on how our STEMVACS-V stacks up with KRAS of AMGEN to get an idea how we can compete or partner with BIG GOLIATH like AMGEN. thanks in advance
curncman
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Re: Questions for Tim

Post by curncman »

Hope FDA is going to offer same priority status to our JADICELLS to treat lung damage due to SARS-COV2/ARDS condition. TSOI has put its hand up since a Looooong time to treat with STEMCELLS. Its about time for FDA to open the gates for stream of IND approvals to TSOI and amny other biotechs with innovative stemcell approaches!


Biotechnology stocks are famous for dramatic price movements but smart investors have been eager to scoop up shares of Amgen (NASDAQ: AMGN) for a different reason. Despite its size, Amgen can move quickly where it matters most. On May 28, 2021, the FDA granted a highly accelerated approval to a new lung cancer therapy in record time.
Codycrusher
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Re: Questions for Tim

Post by Codycrusher »

I feel like the people in power have the right to push FDA to pick favorites, if the people in power benefit off a certain company’s scientific/whatever going through the FDA phases, the FDA will accelerate there speed in record time for that said company and screw the rest because the rich are in control and almighty and all powerful in there eyes. The rest of the little boys like TSOI the FDA does not accelerate or push to be fast and accelerate at record time because we don’t have the eyes of the richy rich people and they won’t extremely benefit off this company exploding.
It’s all about the rich people and what they want and what benefits there pocket book the most.
You should know the majority of the FDA are controlled by the rich, they got there pockets in everything.
TSOI_Ry
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Location: Seattle, Wa

Re: Questions for Tim

Post by TSOI_Ry »

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. 🤓🍻
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TimGDixon
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Re: Questions for Tim

Post by TimGDixon »

Hi Everyone - ill answer these when i get back. i'm leaving idaho and heading to california right now.
Tim
curncman
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Re: Questions for Tim

Post by curncman »

I just thought it would be great if Dr.Ichim or Famela or Dr.Veltmeyer could answer some of the questions as it would be taxing on Tim to answer most of them.

I would think after answering 7th round of questionnaire from FDA for the Phase 3 trial initiation , makes us believe that we are closely being monitored by Big Pharma with their prying eyes and sending signals thru mediators for deal negotiations with low balling offer to start with and then finally when they hear about the FDA approval ONLY THEN they are going to end up paying way more than what they could have paid prior to FDA approval. :lol: :lol: :lol: :lol: :lol:

it happens all the time and which has been the nature of playing this game of licensing and buyouts in Pharma Industry for decades it has been happening. Now TSOI is in the center of attention of deal making that will make many heads turns in the market!
dneedle280
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Joined: Fri Feb 26, 2021 7:45 pm

Re: Questions for Tim

Post by dneedle280 »

Good Morning Tim, How long is the drive for you from California to Idaho? It seems like one heck of a long drive. Sure hope you got some relaxation in why you're up there. And not work too hard.
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TimGDixon
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Re: Questions for Tim

Post by TimGDixon »

Dneedle's question is easy to answer. Its about 22 hours up there from oceanside. We had 6 full days in idaho and weather was spectacular. I'll post some pics later when i get a chance.
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TimGDixon
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Re: Questions for Tim

Post by TimGDixon »

I think what is important here is the breakthrough in that oncologists can now screen their lung cancer patients for the G12C mutation which will ultimately provide better care and outcomes for those patients with that mutation.

StemVacs assumes a cancer exists and depending on its particular stem cellness can be targeted with SVV by way of gene editing and transfection of a antigen specific peptide, protein, etc. for targeted therapy. My suspicion is that many of these patients will have a CSC (cancer stem cell) that expresses CD133 and if thats the case - we can kill it dead without AMGEN.
curncman wrote: Sun May 30, 2021 8:43 am Hi Tim, I came across this article on Yahoo FDA approves Amgen drug for lung cancer with specific mutation

https://www.yahoo.com/news/fda-approves ... 07760.html

Deena Beasley
Fri, May 28, 2021, 12:59 PM
By Deena Beasley

(Reuters) -The U.S. Food and Drug Administration on Friday approved an Amgen Inc drug for lung cancer patients with a specific mutation in a gene known as KRAS whose disease has worsened after treatment with chemotherapy or other medicines.

The drug, sotorasib, which will be sold under the brand name Lumakras, shrank tumors with the KRAS mutation in around 36% of patients in clinical trials.

The medication is designed to target a gene mutation known as KRAS G12C that occurs in about 13% of non-small cell lung cancers (NSCLC), the most common type of lung cancer.
Amgen said the drug will have U.S. list price of $17,900 per month. Wall Street analysts, on average, expect 2022 sales of $240 million, according to Refinitiv data.


When u have free time I was wondering if you throw some light on how our STEMVACS-V stacks up with KRAS of AMGEN to get an idea how we can compete or partner with BIG GOLIATH like AMGEN. thanks in advance
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