Remember...

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TimGDixon
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Joined: Fri Mar 18, 2022 12:00 pm

Re: Remember...

Post by TimGDixon »

Let me add; I have promised all of you I will not reverse your holdings and nothing will change that. Maybe thats whats been going on since dec 21. Slow accumulation by a loosely affiliated group to either force a reverse, force a proxy challenge, or maybe a good old fashioned hostile take-over. Well, none of that is possible anymore with Series A in place now is it.
“And the corner sign says it's closing time so I'll bid farewell and be down the road...”
jluedke60
Posts: 17
Joined: Fri Mar 18, 2022 4:06 pm

Re: Remember...

Post by jluedke60 »

In my opinion, TSOI is too good, they are doing too much. Investors are focused on one thing and invest in that item. TSOI has so many different areas of, lets say interests, people that invest do not want their investment to go to the whole cause (TSOI), they might be more interested solely in COPD or JADICELL or Cancer cure....this is why I think Tim is moving in the right direction with these spinoffs. This allows an investor of COPD to focus their investment or support to that one area instead of the entire company where they don't know what percentage will go where.
rrao11
Posts: 162
Joined: Sat Mar 19, 2022 10:20 am

Re: Remember...

Post by rrao11 »

Agreed that market isn’t right all the time, actually many times. Unfortunately, that’s what dictates pps. Hence my thoughts on the topic.

Agree also that it’s not helpful to sell cheap paper to raise funds and I like the idea of spin-offs to raise funds without diluting $TSOI. In the long term, that’ll be the right thing to do.

But, the moment the market hears any of their ‘key words’, the pps will run and keep running! It’ll happen!

Again, IMO :D

WEN X 5
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TimGDixon
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Re: Remember...

Post by TimGDixon »

I agree with the sentiment of both of you (jluedke60/rrao).
“And the corner sign says it's closing time so I'll bid farewell and be down the road...”
ND2020
Posts: 149
Joined: Sat Mar 19, 2022 12:48 pm

Re: Remember...

Post by ND2020 »

99crumleymg wrote: Wed Sep 07, 2022 3:03 am The catalyst you assume is months away, many months and is surely no 'lock'...............without a near term jolt of legit good news, im not talking IP the street obviously doesnt care,(minor partner on anything) its going to fall under one penny and will not look good to any potential investor who looks at the horrific chart of this stock. Im no expert and im not criticizing Tim but in my 25yrs of bio exp, most will trade on future prospects, is this doing that?? Ph-3 stemcell and nobody bats an eye?? Why is that?? Not a single day of DD gains?? Even if it gave it back a few days later?? Why arent the shorts scared stiff bout being obliterated at any moment?? That has to be answered because they have no fear, theyre laughing about it, they need to digest some 'punch in the face' news, than lets see how funny it is.......
The guidance from FDA on this website, states the following:
  • Review Time for initial submission of an Investigational New Drug application is 30 days from the date FDA receives the IND. An IND applicant may proceed with a clinical investigation once the applicant has been notified by FDA that the investigation may proceed or after 30 days if the IND is not placed on Clinical Hold.
This is in alignment with following clauses of 21 CFR 312.40:
(b) An IND goes into effect:

(1) Thirty days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold under § 312.42; or

(2) On earlier notification by FDA that the clinical investigations in the IND may begin. FDA will notify the sponsor in writing of the date it receives the IND.
So, my read of the statute is that response from FDA is expected within 30 days or the IND can proceed with the amended protocol otherwise, unless FDA puts a clinical hold.

Tim, can you please comment on if the above interpretation of the statute is correct?
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TimGDixon
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Re: Remember...

Post by TimGDixon »

Well there are timelines and then there are timelines. We would never proceed without clearance as a rule of thumb even if som regulation says no reply in 30 you can proceed. Always better to have them on your side. This is an amendment and so we'll have to let it play out.
“And the corner sign says it's closing time so I'll bid farewell and be down the road...”
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ttessier
Posts: 155
Joined: Sat Mar 19, 2022 5:40 pm

Re: Remember...

Post by ttessier »

Thank you for that!
TimGDixon wrote: Wed Sep 07, 2022 4:57 am Let me add; I have promised all of you I will not reverse your holdings and nothing will change that.
Very smart to issue the Series A. You and Tom maintain control.
TimGDixon wrote: Wed Sep 07, 2022 4:57 am Maybe thats whats been going on since dec 21. Slow accumulation by a loosely affiliated group to either force a reverse, force a proxy challenge, or maybe a good old fashioned hostile take-over. Well, none of that is possible anymore with Series A in place now is it.
noslippas808
Posts: 44
Joined: Mon Mar 28, 2022 2:41 pm

Re: Remember...

Post by noslippas808 »

TimGDixon wrote: Wed Sep 07, 2022 4:43 am
rrao11 wrote: Tue Sep 06, 2022 11:45 am That’s an impressive list.
Unfortunately, IMO, the market thinks that $TSOI needs to significantly dilute to raise funds to support all the work that needs to be done, irrespective of what Tim has said on the forum. Additionally, the market looks for ‘key words’ like ‘partnerships’, BO, sale of IP, Revs, etc. and we are waiting on that front. Therefore, the market has not recognized or understood the list and hence, $TSOI is sooooo significantly undervalued. JmHO

Hopeful that at some point, someone will notice $Tsoi and ii’s work.

Wen x 5
The "market" isn't always right unless the goal is to make me wrong. Sure we can sell boat loads of cheap paper to fund things but why should we when we can just out-license patents to our own majorly owned subs and raise capital privately. Isn't the goal to mature the intellectual property we own? And if that is the case we either do it all here or we do it outside or some combination thereof. Fall is just around the corner and snow will soon be here... better get on down the road I think...

bro u do what ever you need to do.. i fight these bashers on ST with common sense and ive found out they are of no concern. ST is not gonna decide or affect the share price no matter how much they think they can. our share price dropped as well as everyone else.. OCGN is in phase 3 with a viable covid vaccine from india.. i was in that stock, the FDA and W,H.O fuuuuucked us. made us do a phase 3 all over again. even with that said wwe couldnt hold our 11 dollar stock, even with funding and a viable vaccine. now its at 2 bucks.. ive been with quite a few biotech's and nobody can change share price up or down but huge catalyst.. so with that said, go do you, get ur funding the safest way u can. timelines to me aint a concern. ill still be here in 5yrs after ur in every hospital..
curncman
Posts: 544
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Re: Remember...

Post by curncman »

TimGDixon wrote: Wed Sep 07, 2022 7:51 am Well there are timelines and then there are timelines. We would never proceed without clearance as a rule of thumb even if som regulation says no reply in 30 you can proceed. Always better to have them on your side. This is an amendment and so we'll have to let it play out.
Series A restricted shares will give extra protection against Hostile Takeover. But given all the circumstances it will help TSOI shareholders if IP (couple of patents out of 68 patetns) is sold for even atleast 200 million ..just my 2 cents
I am well wisher of everyone! GOD will pardon all your sins but not your Central Nervous System! Think Positive!
curncman
Posts: 544
Joined: Sat Mar 19, 2022 10:10 am

Re: Remember...

Post by curncman »

Folks! also remember TSOi is dealing with GOLIATHS like Pfizer , Glaxosmith, Merck and Eli Lilly who have limitless supply of funds, friends at high places all over teh world. its tough for TSOI to break the glass ceiling that ELON MUSK was able to dent and break thru that IRON curtains laid by FORD ,GM, DIAMLER BENZ.

ELON definitely showed the world how to get it done. Now TSOI has to follow the same approach be successful

Also TSOI has about close 70 patents and several of them are valued in billions and some are in 100s of millions. They have plenty of options to strike any kind of deal to get us out of this PPS RUT into dollar range.
I am well wisher of everyone! GOD will pardon all your sins but not your Central Nervous System! Think Positive!
curncman
Posts: 544
Joined: Sat Mar 19, 2022 10:10 am

Re: Remember...

Post by curncman »

This is the kind RAW power that BIG PHAROAHS command at the highest level

Providers report dozens of errors giving Pfizer's COVID vaccine. Experts worry new boosters will fuel more

https://www.yahoo.com/news/providers-re ... 57604.html

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I am well wisher of everyone! GOD will pardon all your sins but not your Central Nervous System! Think Positive!
curncman
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Re: Remember...Gilead's Trodelvy extends breast cancer survival by 3.2 months -study

Post by curncman »

Gilead's Trodelvy extends breast cancer survival by 3.2 months -study

https://finance.yahoo.com/news/gileads- ... 00538.html

Sept 7 (Reuters) - Gilead Sciences Inc's Trodelvy extended by 3.2 months the survival of patients with advanced stages of a common type of breast cancer, according to data released ahead of a presentation at a European cancer meeting on Friday.

Put another way, the Gilead drug reduced the risk of death by 21% in the Phase III trial.

The company has said the results are both statistically and clinically significant.

The study being presented at the European Society for Medical Oncology's annual meeting in Paris compares Trodelvy to chemotherapy in 543 patients with hormone-sensitive tumors that test negative for a receptor called HER2 and who had stopped responding to at least two earlier courses of therapy.

Gilead said interim results from the trial show overall survival for those who received Trodelvy of 14.4 months compared with 11.2 months for chemotherapy patients. Details including the number of patients included in the interim analysis will be released on Friday.

Trodelvy, also known as sacituzumab govitecan, uses a tumor-targeting antibody to deliver an anti-cancer drug.

"The only option for these patients is chemotherapy," Bill Grossman, head of oncology at Gilead, told Reuters. "I think it's going to be a game changer for these patients going forward."

The data release comes after Gilead in March said the breast cancer study met its main goal of reducing the risk of cancer progression or death, but did not disclose any details.

The company reported some additional details in June, saying the trial met its primary goal by showing progression-free survival - the time until the disease begins to worsen - of 5.5 months for the Trodelvy group versus 4 months for chemotherapy patients.

It also disclosed that the first analysis showed Trodelvy patients lived a median 13.9 months, compared to 12.3 months for the chemotherapy group - a difference that was not statistically significant.

Gilead said last month it had applied for U.S. approval of Trodelvy for pre-treated hormone receptor positive/HER2 negative metastatic breast cancer. The drug is already approved in the United States for previously treated metastatic triple-negative breast cancer and bladder cancer. It is being studied for use in a number of cancer types.

Trodelvy's label includes a warning for low white blood cell counts and severe diarrhea.

Wall Street analysts have questioned demand for Trodelvy given competition from Enhertu, an AstraZeneca Plc and Daiichi Sankyo drug that was approved last month for breast cancer patients with low levels of HER2.

Analysts, on average, expect annual Trodelvy sales to reach $1.9 billion by 2026, according to Refinitiv. (Reporting By Deena Beasley Editing by Bill Berkrot)
I am well wisher of everyone! GOD will pardon all your sins but not your Central Nervous System! Think Positive!
curncman
Posts: 544
Joined: Sat Mar 19, 2022 10:10 am

Re: Remember...Future vaccine development may be inspired by the findings.

Post by curncman »

Future vaccine development may be inspired by the findings.


https://scitechdaily.com/powerful-new-a ... iants/amp/
I am well wisher of everyone! GOD will pardon all your sins but not your Central Nervous System! Think Positive!
curncman
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Joined: Sat Mar 19, 2022 10:10 am

Re: Remember...Roche snaps up PD-1-focused Good Therapeutics for $250M; 'Sky's the limit' for spinout

Post by curncman »

Roche snaps up PD-1-focused Good Therapeutics for $250M; 'Sky's the limit' for spinout

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Roche has paid out $250 million cash to acquire Good Therapeutics as part of a bid to bolster its immuno-oncology efforts with the Seattle biotech's preclinical PD-1-regulated IL-2 program.

The Swiss pharma giant will be fully responsible for the global development and commercialization of a PD1-regulated IL-2 receptor agonist program, while the rest of Good Therapeutics’ assets will be shifted over to a new spinout dubbed Bonum Therapeutics.

“Good Therapeutics showed that the concept and technology—the idea of a shape-shifting protein that changes its activity in response to a signal—works,” John Mulligan, Ph.D., founder and CEO of Good Therapeutics, told Fierce Biotech. The company proved its tech’s worth once and will do it again, according to Mulligan, this time with preliminary work for half a dozen programs already in hand.

Under the merger—which is set to close in the third quarter of this year—Good Therapeutics will also be eligible for development, regulatory and commercial milestone payments from Roche. The Big Pharma didn’t disclose further financial details, though Roche’s head of oncology and pharma partnering Patrick Schleck said the overall deal package is “in line with comparable transactions and reflects both the early nature of the program and its future high potential.”

Conditionally active therapeutics are a new class of investigational drugs designed to offer potent activity only where it is needed. Good’s context-dependent molecules combine an antibody sensor directed against a specific marker and a therapeutic component that activates only when the sensor has bound to its target. The therapeutic component can be regulated by any molecule that an antibody can bind to, and the shape of the molecule is determined by the antibody bonding.

The PD-1-regulated IL-2 program now under Roche’s umbrella is designed to deliver potent IL-2 stimulation of T cells without the toxicity that can limit unregulated IL-2 therapeutics. Roche's Schleck said the preclinical program demonstrated excellent in vitro and in vivo data. Though he couldn’t reveal specific clinical timeline goals, the executive said Roche believes PD1-regulated IL-2 could become the new backbone for checkpoint-inhibitor-based therapies and help target broader patient populations.

RELATED
7 months after announcing a pivot to drug discovery, Zymergen is acquired by Ginkgo
Founded in 2016, Good Therapeutics was based on two main ideas: to make drugs that regulate their own activity and to sell programs—not platforms, the biotech's CEO explained. The Roche deal validates both of those ideas, Mulligan said.

“We’re super excited about having Roche take this program,” he said.

When asked whether the prolonged bear market—which has prompted a gaggle of biotechs to cull pipeline programs and staff alike—played a part in the deal, Mulligan said the acquisition was a long time coming and negotiations had started before the downturn. However, he acknowledged that the market conditions had some impact, as it has on everyone in the industry.
I am well wisher of everyone! GOD will pardon all your sins but not your Central Nervous System! Think Positive!
curncman
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Re: Remember...The role of allogeneic transplant in myelofibrosis and important factors to consider

Post by curncman »

The role of allogeneic transplant in myelofibrosis and important factors to consider








I am well wisher of everyone! GOD will pardon all your sins but not your Central Nervous System! Think Positive!
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