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Re: Remember...

Posted: Wed Sep 07, 2022 4:57 am
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.

Re: Remember...

Posted: Wed Sep 07, 2022 5:30 am
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.

Re: Remember...

Posted: Wed Sep 07, 2022 5:36 am
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

Re: Remember...

Posted: Wed Sep 07, 2022 5:58 am
by TimGDixon
I agree with the sentiment of both of you (jluedke60/rrao).

Re: Remember...

Posted: Wed Sep 07, 2022 7:44 am
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?

Re: Remember...

Posted: Wed Sep 07, 2022 7:51 am
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.

Re: Remember...

Posted: Wed Sep 07, 2022 8:22 am
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.

Re: Remember...

Posted: Wed Sep 07, 2022 4:57 pm
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..

Re: Remember...

Posted: Wed Sep 07, 2022 8:14 pm
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

Re: Remember...

Posted: Wed Sep 07, 2022 8:43 pm
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.

Re: Remember... Is Fauci’s prediction of an annual COVID vaccine an attempt to ‘gaslight

Posted: Sun Sep 11, 2022 11:57 am
by curncman
Is Fauci’s prediction of an annual COVID vaccine an attempt to ‘gaslight’ people that it’s just like the flu?

Re: Remember...

Posted: Fri Sep 23, 2022 12:55 pm
by Codycrusher
Can’t stand mandates, I haven’t had 1 booster shot, I would rather get Covid than get a booster shot any day of the week but I take Quadramune and nanostilbene so I’m sure those would help too.
I am anti Covid booster shot.

Doctors are prescribing the weight loss drug semaglutide. Here's what you need to know, according to experts and people

Posted: Wed Oct 05, 2022 4:52 pm
by curncman
Doctors are prescribing the weight loss drug semaglutide. Here's what you need to know, according to experts and people who have tried it.

Image
Semaglutide, also known by the brand names Ozempic and Wegovy, is quickly becoming a popular weight-loss medication. (Getty Images)
Like nearly 50% of Americans, Talia (not her real name) had gained weight over the pandemic and wanted to do something about it. After a friend lost 40 pounds using semaglutide — a prescription injectable weight-loss medication that’s garnering a lot of buzz right now — her interest was piqued.

The New York resident made an appointment with her friend’s doctor and asked about any potential risks and whether she needed to follow a specific diet while on the medication. “I was told that in clinical trials, participants lost an average of 15% to 20% of their body weight without adhering to a special diet,” Talia tells Yahoo Life. She adds: “It sounded like it was worth trying, so I decided to move forward.”

Talia started the once-weekly injections of semaglutide (also known by the brand names Ozempic and Wegovy) in July 2021 and began losing around 4 to 5 pounds per month. “I think around Christmas, I noticed a change in my face — where I tend to carry weight — and after the Christmas holiday, my co-workers started commenting on my appearance,” she says.

She eventually lost 50 pounds, reaching the significant weight-loss goal she’d set for herself. “I am very happy with the results,” Talia says. “I had hoped to reach the goal sooner, but I do not exercise, so I expect that slowed the process a bit.”

Vanessa (last name withheld) heard about semaglutide from a medical practice she works with, after the owner lost 30 pounds in five months on the medication. Impressed with her results, Vanessa decided to try it herself. “It seemed like a healthier way to go about weight loss versus eating frozen processed foods, counting calories, etc.,” the Washington resident tells Yahoo Life.

Although she already exercises regularly and eats healthfully, Vanessa has made some lifestyle changes since starting semaglutide. “I would say that the biggest changes I made were eating more proteins, drinking more water — and adding electrolytes to my water — and eating more greens,” she says. “My body actually really craved that. It also forced me to eat smaller portions, as semaglutide sort of tricks your brain into feeling full, and you aren’t craving sugar.”

She also found herself less interested in drinking alcohol. “My body sort of rejects it after one to two drinks,” Vanessa says. “It’s the strangest thing, but I am not complaining!”

Within two months, she had lost 10 pounds. Now, in her 11th week, she is down 14 pounds. “I am very pleased,” Vanessa says.

It’s hard to read about results like these — all achieved without highly restrictive eating plans and punishing workout routines, the usual hallmarks of diets that promise significant weight loss — and not view semaglutide as some sort of magic bullet.

But how does semaglutide help with weight loss? Is it safe? And does it actually keep the weight off? Here’s what you need to know, according to experts.

First, how does semaglutide help with weight loss?
Semaglutide was developed as a medication for type 2 diabetes, garnering FDA approval in 2017. However, clinical trials and post-marketing surveys “clearly demonstrated that the drug also has the capability of helping people lose weight,” Dr. Zhaoping Li, chief of clinical nutrition and professor of medicine at UCLA Health, tells Yahoo Life.

In February 2021, the FDA approved semaglutide for chronic weight management in adults who are obese or overweight and have at least one weight-related health condition, such as high blood pressure, type 2 diabetes or high cholesterol. Before that, it had been seven years since the FDA approved a drug for chronic weight management. Currently, that small list of approved prescription medications includes drugs such as orlistat (Xenical), liraglutide (Saxenda), bupropion-naltrexone (Contrave) and phentermine-topiramate (Qsymia), according to the Mayo Clinic.

Dr. Claudia Ramirez Bustamante, fellow physician of medicine-endocrinology at Baylor College of Medicine, tells Yahoo Life that semaglutide is “very effective” for weight loss. A 2021 study on semaglutide in the New England Journal of Medicine found a 15% reduction in body weight, while Bustamante points to a 2022 extension of the original study, which shows that participants lost an average of more than 17% of their body weight while on 2.4 mg of the medication. For a 175-pound person, for example, 17% is a loss of nearly 30 pounds.

Given that people on other prescription weight-loss medications lose, on average, 3% to 12% of their body weight after a year, it’s not surprising that semaglutide’s results are leading some experts to call the medication a “game changer.” As Li puts it: “It’s great to add another tool to our toolbox.”

So how does it work? Semaglutide helps control blood sugar by stimulating insulin secretion, while protecting against cardiovascular problems. The medication also causes a “minor delay” in gastric emptying, which contributes to people feeling fuller longer and therefore eating less.

“Semaglutide slows gastric emptying, thus making the absorption of nutrients slower in the gut,” explains Bustamante. “In addition, it acts in the areas of the brain involved in appetite regulation. In practical terms, patients taking semaglutide have decreased appetite and feel satiated with smaller portions, which lead to weight loss.”

What are the side effects?
The medication is not without its downsides. The main side effects of semaglutide are abdominal pain, bloating, nausea, vomiting, diarrhea or constipation, explains Bustamante. But they’re temporary. “Usually, these side effects tend to wear off after one to two weeks,” she says. “However, in some patients they can persist and warrant dose adjustments and, if severe, discontinuation of therapy.”

Vanessa shares that she experienced “nausea, gas pains and fatigue initially” but adds that once the side effects “calmed down, it was a pretty seamless way to lose weight.”

Your bank account, however, may also suffer some side effects. That’s because the cost of the drug is “substantial,” says Li — about $1,300 per month for four shots. “There is also insurance coverage issues for weight loss,” she says, referring to the fact that the pricey drug may not be covered.

It’s not clear why insurance doesn’t always cover semaglutide for weight loss if it’s FDA approved, but several factors may be at play. One possible reason may be the sheer volume of the potential patient population who might seek coverage, given that nearly 1 in 3 adults in the U.S. is overweight and more than 2 in 5 adults have obesity, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Another reason may be that insurance companies have had “plenty of lessons learned from multiple drugs that had to be withdrawn from market despite their efficacies,” Li says, pointing out, for example, the once popular weight-loss drug combination fenfluramine-phentermine, known as fen-phen, which was also viewed as a “miracle” but was pulled off the market in 1997 for causing heart valve damage.

Are there any risks?
Yes, say experts. “There is a risk of progression of diabetic retinopathy,” says Bustamante, referring to a diabetes complication caused by damage to the blood vessels at the back of the eye. “There is also a risk of acute pancreatitis. Thus, this medication would be precluded in patients with chronic pancreatitis or pancreatic neoplasia [pancreatic cancer].”

Semaglutide is not recommended for people with a personal or family history of thyroid cancer (in particular, medullary thyroid cancer) because the medication may increase the risk for that, according to Li.

Does the weight come back after stopping the medication?
Both Talia and Vanessa have some concerns about how stopping the medication will affect their weight. “I do wonder what will happen when I stop taking the injections, and worry that if I do, the weight may come back,” says Talia.

That’s a legitimate concern given that research shows people who lost weight on 2.4 mg of semaglutide regained two-thirds of the weight they’d lost within a year of stopping the drug, “suggesting that this medication should be taken indefinitely to maintain weight control,” says Bustamante.

For Vanessa, she says that knowing there is a “maintenance program” helps, and “I do think it weans you off in a good way.” She adds: “The idea is to have changed various habits and stick with that. I am committed to keeping it off, and that is half the battle with weight loss programs.”