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Dr. Patterson in his second video with Dr. Yo was asked how easy would it be to make a mab like Leronlimab. I don't recall Patterson's exact reply, but the gist of it was yes, other companies will try to come up with their own CCR5 modulator, but no one should worry about competition for Leronlimab. It would take years and years to develop and billions in research, and even then it would be very unlikely to come up with a drug as perfect as leronlimab. He called Leronlimab eloquent and unique in the way that it allows the immune system to function as it should, all without side effects.
I think it's rather ironic, actually, that after Leronlimab's success with EIND's, that Fauci suddenly boarded the mab train, and though he wouldn't utter the "grandaddy of all mabs" name, he did state that mabs would be the solution and encouraged big pharma to come up with their own. The result: Ely Lilly and Regeneron's early onset mabs, which are proving to be impractical for wide-spread use and administration, and unlikely to still be effective with new mutations.
Yes, Diesel, that's the best outcome! Phase 4, no placebo group. EUA now and gather more data for full approval.
Longhauler phase 2 enrollment is full and there is a waiting list for the follow up trial. https://twitter.com/Aardslonghauler/status/1377396074378190850
I agree. While these hedge funds are a nuisance, they sure are providing great buying opportunities for investors. I've increased my position tenfold.
I wish I could believe that headline Bunky, but it doesn't make sense with cases now on the rise, virus escaping mutations, EU lockdowns and phase 4 predictions. Just three hours ago the CDC warned of "impending doom." Sounds like there is going to be tremendous need for Aviptadil. https://www.cnn.com/videos/health/2021/03/29/cdc-walensky-warning-30-million-cases-vpx.white-house
A big hedge fund has failed and Credit Suisse, J.P. Morgan and other banks are taking a huge hit. The margins were called and they are having to liquidate $40 billion in stocks. This is impacting the markets in a big way. https://www.cnn.com/2021/03/29/investing/credit-suisse-nomura-archegos-capital-intl-hk/index.html
Hopefully this market instability and gamestop fallout will be over by the time the EUA is granted, so this stock can fly in clear skies.
Black Rock or Big Rock? Can you point me to where you found this info? Thanks
I think you're right Samuel J. I remember reading about the billions of dollars that hedge funds lost due to GME, and how Citadel bailed some of them out. They are still behind and picking the pockets of OTC retail investors. https://www.cnbc.com/2021/01/31/melvin-capital-lost-more-than-50percent-after-betting-against-gamestop-wsj.html
I also heard that the government gave financial institutions and hedge funds money to keep the markets from collapsing due to the pandemic, and that hedge funds used those free funds to short stocks. Now they have to cover, which means they will drive it down as far as they can before their gravy train ends on 3/31. https://twitter.com/TTrader1976/status/1375108048499445761
My strategy: hold or buy more at these bargain prices.
CDEL has been trashing a ton of OTC stocks, artificially manipulating the ask and pulling their bids before they get filled. I thought market makers were just supposed to trade in the gaps, not manipulate. Can anyone explain what's going on? Are they being super aggressive to make up for their losses on gamestop? Don't they need the stocks to run to make $$ too?
PM will now send in a written reply to HCMC's response. With every motion and response it is customary to include a proposed order for the court's use. This is an unsigned draft order. It won't be ruled on or signed until the the motion is heard at a hearing in April. There will be a tentative ruling the day before the hearing, which will tell you which way the judge is leaning and then there will be oral argument by both sides at a hearing. Then the judge will make a final ruling and the proposed order will be finalized, signed and entered by the court.
Tulla, do you know if the new rule applies to OTC as well? Thanks
If that's the case, then that's good news, because Leronlimab modulates CCR5 which controls GM-CSF.
I agree. This is my concern as well. Our Phase 2b/3 ended up being a phase 2. I hope they hit it out of the park with the 140 patients. Can our p values with only 140 patients compare to the larger NIH trials?
Yes, please send it to Cytodyn. This is important. I didn't know that it wasn't required for miraviroc. Why are they requiring it when other countries do not?
Send that to corporate.
Can someone please explain what Brian is talking about here? Thanks so much.
RLF100 Added 60 Days to all endpoints. Why can't we?
The FDA has updated its guidelines for therapeutic trials. They are now recognizing that judging mortality benefit at 28 days for critical patients is not an accurate picture due to improvements in standard of care. They are recommending following patients for 60 days. See Page 12: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry. https://www.fda.gov/media/137926/download
"In a trial in severe and/or critically ill patients, examples of appropriate endpoints could be: All-cause mortality at an appropriate time point (e.g., at least 28 days for hospitalized noncritically ill patients, 60 days for critically ill patients). "
NeuroRX is trialing RLF-100 (Aviptadil) and completed their trial around the same time we did. After unblinding, the FDA allowed them to modify both their primary endpoint and secondaries to allow for 60 days. Here is their PR about it. https://www.neurorxpharma.com/press-releases/...gh-flow-n/
On February 23, 2021 they updated their trial protocol. As you can see, 28 days became the “interim" and "day 60” was added to a majority of their endpoints . See comparison here: https://clinicaltrials.gov/ct2/history/NCT043...udyPageTop
Rather than start again with new patients, why aren’t we asking the FDA to add 60 days to our endpoints? Wouldn’t all of our data be more meaningful and significant at the 60 day point? This would capture the SOC patients that were severe and ended up critical or relapsing as well. That would give us a much broader picture of Leronlimab’s efficacy. Since we already are accumulating that data, wouldn’t that be better and quicker than starting a new group? Can we ask the FDA to do this?
Are we stuck pleading our case to the assigned evaluator or can we make our case directly to Woodcock? She has repeatedly said that P value is not as important for the severe/critical patients during a pandemic and that an EUA will not require it.
The FDA has acknowledged that with improvements to standard of care that 28 days is not sufficient to judge mortality benefit. The FDA is now recommending that trials follow patients for 60 days.
Like Cytodyn, RLF-100’s trial just concluded a few weeks ago. They were able to add the words “60 days” to their primary endpoint and are reviewing that data now. Why can’t Cytodyn do the same? Wouldn’t they be more likely to be statistically significant at 60 days? Wouldn’t that help with the other points as well?
Great DD chunky-g! You found some excellent stuff today. Thanks for sharing. I need more shares!
Thanks for posting this. I don’t understand why they are writing up the 28 day data like this though, when the 60 day should be just a few weeks away and should be much more significant. Can anyone shed some light on this? I know it takes a long time to get published in medical journals. Can they addi that data and analysis before it gets peer reviewed?
I agree. There has definitely been some algorithm trading going on where the price is lowered then kept steady throughout the day while some entity loads up. I call that barcoding, because that's what it looks like on the chart. I didn't see much barcoding on Friday so perhaps GEM is done? Assuming you are correct, would you agree that it is now in GEM's best interests to allow the price to go up so they profit?
As a long investor who is already loaded up, I'm not happy about the reduction in share price that's for sure, nor do I appreciate the mixed messaging in their PR's, but in my opinion the share price is not particularly relevant at the moment, at least not until an EUA is granted. I don't think GEM is in the business of losing money, so they aren't going to get further invested if they don't believe in the product. Also, the addition of this stock to the small cap index is very promising. I'm hoping we'll all go along for the ride up.
I can’t speak to the CEO’s previous ventures, but the company behind this stock PCTI, has been in business for 30 years and is a solid company with many contracts with the military. https://pcti.com/
“ PM is taking a flyer to introduce outside factual claims into a pleading without offering expert testimony under oath. Any lawyers feel free to chime in, but that doesn't seem like something a judge would be inclined to dismiss without a trial. ”
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Exactly correct. Questions of fact are supposed to be decided by a jury. This is a very weak motion and I expect it will be denied.
Normally when a motion is filed, the opposing party will be given time to file their own response to it before the judge makes a ruling. The date in March is probably for HCMC's response.