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More, re: the DSMB and Dr. Hayden. The really sad thing is, early on in the pandemic everyone thought Dr. Fauci was helping the effort to save lives, he was considered a hero. Having a doctor affiliated with him on our DSMB would have been something we would have been happy about. We would have cheered: "Yay, Dr. Fauci will learn about our wonder drug."
Now that we know a lot more about Fauci/Gilead and the treatment of Remdesivir, we realize that it was actually our downfall. I was one of the naive believers in Fauci too.
In other news, the FDA will be changing it's name soon. Some of the new names up for consideration: the Fdelay and the GDA, the Gilead Drug Administration.
The CD12 trial was a combination, phase 2 and 3. Phase 2 is typically where you work out things like dosage, best endpoints, etc. We were at a disadvantage because the trials were combined and not much was known about the disease at that time. The EIND patients were making miraculous recoveries within days, so I understand the urgency and why the trial was combined. Unfortunately, we didn't have good guidance from the DSMB at interim, and we didn't have the benefit of the adaptive protocols developed later on in the pandemic. Looking back, it's easy to armchair quarterback and question everything. Additional trials should prove our MOA and dosage regimen.
Dr. Hayden and Dr. Fauci are close associates. They’ve authored research papers together. Dr. Hayden has been active in the Remdesivir trials and vocal in his support of the drug, including stating that Remdesivir will be the standard of care. He is a known consultant FOR Gilead. How did he end up on the three member DSMB for Cytodyn's CD12 trial? That is a major conflict of interest. Committee members are supposed to be free of conflicts:
Conflict of Interest
No member of the DSMB should have direct involvement in the conduct of the study. Furthermore, no member should have financial, proprietary, professional, or other interests that may affect impartial, independent decision-making by the DSMB. Letters of invitation to prospective DSMB and ad hoc members should include the following: "Acceptance of this invitation to serve on the xxx DSMB confirms that I do not have any financial or other interest with any of the collaborating or competing pharmaceutical firms or other organizations involved in the study that constitute a potential conflict of interest." In addition, all DSMB and ad hoc members will sign a Conflict of Interest certification to that effect at the time they are asked to participate. At the beginning of every DSMB meeting, NIDCR program staff or the DSMB Chair will reconfirm that no conflict of interest exists for DSMB members. Interests that may create a potential conflict of interest should be disclosed to the DSMB prior to any discussion. The DSMB will determine how to handle any such potential conflict. The DSMB can require that a member with a potential conflict abstain from voting or take other means deemed appropriate. NIDCR may dismiss a member of the DSMB in the event of unmanageable potential conflict or appearance of conflict.
See: https://www.hhs.gov/guidance/document/guidelines-dsmb
It’s no wonder why Cytodyn didn't get proper guidance from the DSMB.
Here are just a few of the articles containing quotes from Dr. Hayden in support of Gilead:
https://www.statnews.com/2020/04/29/gilead-says-critical-study-of-covid-19-drug-shows-patients-are-responding-to-treatment/
https://fortune.com/2020/04/23/gilead-shares-chinese-trial-coronavirus-drug/
https://www.bloomberg.com/news/articles/2020-04-23/gilead-plunges-after-report-that-chinese-trial-was-unsuccessful
CYDY has a monumental hill to climb. I am so glad they pivoted to other countries. Keep up the good work CYDY.
The critical group in the Cydy trial was a subgroup. That’s not cherry picking.
This is Gilead cherry picking:
https://mkus3lurbh3lbztg254fzode-wpengine.netdna-ssl.com/wp-content/uploads/2578.pdf
Discussion about 2 versus 4 doses:
Min 11:45 @ Oct. 20th, 2020 Conference Call.
Can be found in the IR Calendar link on the CYDY website:
Dr. Lalezari:
" As Nader said, there was the DSMC meeting last Thursday
and during the the intro to the meeting, I had asked the members of the committee
to look at the clinical signals, mortality signals and to specifically address weather we
needed to adjust the dosing. When we had submitted CD10 & CD12, we had proposed
2 doses for the mild to moderate patients, 4 doses for the severe & critical & the FDA
pushed back having to give 2 doses for both study populations. I've never actually been
comfortable with that, and so the question I asked the committee was, was there a signal
that might require Cytodyn to adjust the CD12 dosage. Are there patients who, particularly
critical patients, who might need a 3rd or 4th dose of Leronlimab?"
Not true. There is a transcript of one of the FDA/DSMB meetings where 2 versus 4 doses is discussed.
From JWR on yahoo:
"There are two "facts" in the FDA's statement on leronlimab that are incorrect and material:
1. For the CD10 trial, the announcement stated that "there was no observed effect of the drug on the study’s (CD10) primary endpoint or on any of the secondary endpoints." The NEWS2 score was a secondary endpoint on the trial and met stat sig for the entire population:
"In all treated patients, at the End of Treatment (or Day 14), patients in the leronlimab group were more than twice as likely to experience a beneficial improvement in NEWS2 scores compared to patients in placebo group (50% vs 20% p = 0.0223)."
NEWS2 is material to the study as it is also considered a gold standard for Covid progression and the most objective way to measure compared to symptom score.
2. For the CD12 trial, the FDA stated that the trial "also failed to find any effect of the drug on the primary study endpoint, with no difference seen in mortality...; or on any of the secondary endpoints." CD12 is a multi-arm study and the critical patient population is considered an arm of the study and not a subpopulation. The CD12 study had pre-established criteria for two population segments: severe and critical. For the CD12 study, mortality at 14 day was also a pre-established secondary endpoint. Therefore, for the critical arm the mortality benefit and a p-value of .023 is a valid secondary endpoint.
Note the SIMPLE trial for remdesivir established a 5 day treatment arm and a 10 day treatment arm. There were no required adjustments beyond a baseline adjustment (which adjusts for age distribution or other randomization issues) in the multi-arm Remdesivir study which led to its approval and set the standard for Covid studies going forward.
Treating the critical population as a post-hoc subpopulation is inaccurate and leads to a false perception of the CD12 results.
I appreciate the FDA's transparency but that includes an obligation to be objective and get the facts right. I am hoping they will do a correction."
You have my respect Misiu. Leronlimab will be saving lives all over the world soon.
Perhaps we hear about number of vials, but pricing is confidential. CYDY has a lot and I mean A LOT of balls in the air right now, sending out PR's every other day for their voracious stockholders is probably lower on the list. We literally just got the PR on the Macleods announcement. We are spoiled around here with news. Other biotechs only update once a quarter.
There are those that like to set up false expectations and then shout about it when it doesn't happen.
Exactly EvilRabbit. We shouldn't expect any revenue information until the next 10K.
Nader did not say he was going to be announcing revenue this week, only that CYDY will hopefully be revenue generating this week. He said the amounts would be disclosed in the usual financial filings. So don't act like Nader said he'd be sending out a PR on it. He didn't.
Yes Justdafactss, it's a pre-revenue biotech. This is not new. You would know this if you were a shareholder. Average time for drugs to reach regulatory approval and sales 10 years.
Price was at $2.62. Someone covering a short position perhaps?
I might agree that less said the better, until you have something concrete completed, but I disagree with you about this PR. There is absolutely no way that entering into a distribution agreement with a global distributor (and manufacturer) can be spun into bad news. Shorts can try, but their efforts are getting more and more transparent and desperate by the day. This agreement was a huge achievement and can move the company forward exponentially.
The US approach is so aggravating. It's been clear from the very beginning that Europe and other countries are a few months ahead of us with the pandemic. All we need to do is look beyond our borders to see what's coming and yet we continue to have blinders on and blunder our response. Just a few months ago Fauci was claiming he was "not concerned" about variants coming here. What? Really?
Let's take India, for example. In January, it looked like they were doing very, very well, infection rate was way down and they thought they were on the way to recovery. Two months later and it's a hellish scene of death everywhere.
Dream on USA.
Macleods Pharmaceuticals has contracts and connections all over the world. Here's some of the countries they work in: USA, UK, Europe, Spain, Latin America, Canada, Australia, New Zealand, North Africa, South Africa, East Africa, Ukraine, Kazakhstan, Spain And Indonesia, Russia, Ukraine, Nepal, Myanmar, Sri Lanka, Vietnam, Malaysia, Singapore, Philippines, Thailand, Cambodia, Korea Taiwan, Bhutan & Png Laos, Morocco, Algeria, Jordon, UAE, Oman, Saudi Arabia, Iraq and Yemen.
https://www.macleodspharma.com/international/#:~:text=We%20also%20have%20our%20own,and%20by%20launching%20novel%20drugs.
Cydy management was very smart to pivot to the countries greatest in need. They won't need a big pharma partner. They are already partnering with some of the largest manufacturers and distributors worldwide. Cytodyn and Leronlimab will be a household name very, very soon.
I'm sorry if you already sold or if you are short on this stock. Hopefully, you can get back on board before the train leaves the station.
Macleod Pharmaceuticals also manufactures. They are working with WHO on over 60 drugs right now. Macleod has global reach with distribution and manufacturing. This is extremely promising. I'm sorry that some of you sold already. Small biotech takes ages and the swings are nerve wracking, so I totally understand the frustration. Hold on for big gains.
Just look at all the countries that Macleod Pharmaceuticals services:
https://www.macleodspharma.com/international/
Very bullish. It won’t be long before Cydy is known worldwide.
Wow Bourbon. I keep seeing more and more reports of this. Saw this one yesterday: https://sciencebasedmedicine.org/spike-proteins-covid-19-and-vaccines/
Sounds like the spike protein is very dangerous on its own, even without virus present. That explains the clotting issues with Astra Zeneca and J&J as well.
Good idea. All of those doctors have put their words and videos out there in the hopes that word of the miracle molecule will spread, so I'm sure they would welcome their use. :)
You have a generous heart Misiu and you have earned the respect of everyone on this board. Don't ever stop.
I believe the Albert Einstein Israelite hospital in Brazil and their ARO have run seven other covid trials so I am looking forward to their results:
https://trialsitenews.com/albert-einstein-israelite-hospital-in-sao-paulo-brazil-to-lead-two-large-brazilian-phase-3-trials-investigating-leronlimab-for-covid-19/
Misiu - Learning53 had a great organized list of links: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=163656691
Summary could come from Dr. Bream or Lalezari letters?
Misiu. Did you see my link to Public Citizen? That would be a good one too. Email addresses for researchers on the last page of the report. https://mkus3lurbh3lbztg254fzode-wpengine.netdna-ssl.com/wp-content/uploads/2578.pdf
Misiu. He was a science writer for the New York Times for years. If you scroll down on the first page of this link, his email address is on the left. https://nicholaswade.medium.com/origin-of-covid-following-the-clues-6f03564c038
Great news Calstang!!! Thanks for sharing.
Misiu. This is another group that may advocate for Leron: https://mkus3lurbh3lbztg254fzode-wpengine.netdna-ssl.com/wp-content/uploads/2578.pdf
We need a well written and concise explanation with relevant links. I am traveling at the moment, but didn't Latane or Learning put something like that together?
Excellent read Misiu. This is one of the most well researched and explained articles I've read in a long time. This science journalist has major credibility too. He would be a good one to cover the eventual Leronlimab saga.
Thank you Misiu. I’m glad you were able to confirm it.
The number of doses and size of vials is just speculation at this point. Dr Nicholas was clear patients will get four treatments, that’s one a week. Also, a few conference calls ago, Nader mentioned the vials were not labeled yet, that that would be handled by Chiral and Samsung, so no pictures you’re finding online are relevant to this discussion.
I heard the HGEN call, and like Misiu, I heard 100,000 doses and it takes 3 doses per patient. HGEN’s trading has always been anemic and spotty. As far as I know, HGEN hasn’t filed for an EUA, because they don’t have their manufacturing capability up to speed yet.
Meanwhile, CYDY has the capability to produce millions of vials per month with Samsung and their manufacturing facilities have already been inspected and approved by the FDA.
Interesting, from the yahoo board, the Cydy longhauler trial protocol includes receptor occupancy tests, so that bodes well for the hiv boa submission. Sounds like they’ve figured out the testing issue and that’s why the bla is now on track.
Phase two has already been completed. I know the patients were hoping for some sort of extension so they could continue to get the drug as so many had made big improvements, but I don’t know how an extension would be structured or whether the FDA would allow it.
Great summary of the Philippines situation, Diesel. All positive progress in my opinion.
The MHRA may surprise us. If you recall, they agreed to consider EAP and EIND data for EUA approval. Sure, it’s hard to predict when, but it could happen at any time. There are so many potential catalysts. I wouldn’t want to short this stock right now.
No drug can be confirmed, until it is. Patience.
You do realize that today is April 30, right? LOL. May is SO FAR away. LOL. You sound frustrated. I know it feels like a long time, but I take heart that from what we're hearing anecdotally, patients are making remarkable recoveries. That helps while we wait for data.
So, in my opinion, your demands are unreasonable. It's going to take at least a few weeks for a critical patient to recover. I hope you never find out how hard it is to get your health back after a near death experience. Leronlimab will be a godsend to patients and their families.
The doctors participating in the first round of CSP have to report their results and data to the Philippine FDA in early May. I'm assuming that timeframe was given because patients actually have to have time to recover. Leronlimab may start working within just a few days, but compassionate use patients have to be weaned off of ventilators, move out of ICU's to regular hospital rooms and rehab before discharge, and that takes time. I think you forget just how ill these critical patients are. People that short this stock like to float unreasonable timeframes and then claim failure when they aren't met. We should hear something soon, and that's about as accurate a timeframe as can be predicted right now.