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I bet enrollment in Brazil will be quick too!
Update: https://www.clinicaltrials.gov/ct2/show/NCT04901689
Four weekly IV infusions of Leronlimab. 2 arm randomized 1:1.
Start date: June 2021.
Elon Musk had Tesla, Solar City, AND Space X! @elonmusk https://t.co/lI1sO6TjLw
— Bruce K. Patterson MD (@brucep13) May 25, 2021
Weak BS doesn’t work.
Can you back that statement up with anything verifiable?
Sure. FDA has done a lot of things? Fair? Infallible?
https://silasbitchley.substack.com/p/the-curious-case-of-leronlimab-and
You too!
That’s great. I’m not meeting anybody but Misiu is or has met with some people.
Awesome. They have a job to investigate and I expect they will.
Providing useful and sought information to an existent congressional investigation committee isn’t harassing anyone.
Fabulous!
I hope the right people, doctors give them the right info. L-53’s reference list would be good too.
From Cockadoddledue on YMB: Just received an interesting email! A few weeks ago, I sent an email to the Covid-19 Pandemic Congressional Subcommittee. To be honest, I completely forgot about it. However, literally, 2 minutes ago, I received the following email message:
Hi.........,
I am with the Select Subcommittee on the Coronavirus Crisis under Chairman James Clyburn. I received the information that you sent a couple weeks back, and was wondering if you could have a few minutes to speak with us next week?
Many thanks,
Beth
Beth Mueller
Select Subcommittee on the Coronavirus Crisis
Committee on Oversight and Reform | Democratic Staff
U.S. House of Representatives | Washington, DC 20515
(202) 934-0214
Thank you for doing that Misiu.
I am so sorry for this situation Tom.
Your sentiments are just your sentiments and nobody else’s. Express them as your own, and treat others with respect please.
Tom knows the score. I give great weight to what he says, just like I do Learnin53.
Interesting indeed.
Posted by C on YMB: Remdesivir in India - Top story of the week - India's medical elite announced it is or maybe ending Remdesivir as a COVID 19 remedy due to poor performance. Days ago, Macleods announced a 3 year exclusive agreement with CytoDyn for Leronlimab in India. The timing of these announcements can not be ignored. Macleods has a very large presents in India and as such knows the inner working of the Indian medical system. They have followed the progress of Remdesevir and Leronlimab with the FDA. Macleods came to the same conclusions many of us have
1] Leronlimab is very safe
2[ Leronlimab, if allowed 4 injections on a weekly basis vs 2 as was dictated by the FDA trial, results would have met required end points.
3] Leronlimab can be safely injected out of Hospital setting so it can reach its population.
The FDA letter that just posted and the timing of that letter are revealing. The content of the letter tells us what we already knew - we failed endpoints based on the trial parameters set by the FDA - 2 injections a week apart. Who was on the decision made by 3 people that forced the 2 injection limit - a Doctor "related" to Gilead. Who objected to the 2 injection limitation? Dr. Jay Lalezari who is a leader in HIV and has extensive knowledge of Leronlimab and COVID. The FDA letter also promotes that they will work with CytoDyn on further trials. I believe that is their primary task. Thank you US FDA.
Conclusion - Macleods has game on. Gilead has a problem. FDA is using the letter to save face. Once out of the US, the US FDA has clout but not control over use. India is proof. CytoDyn made the necessary move to advance Leronlimab for its patients, for its shareholders. Its game on and I am all in.
Silent running for a while is in order. Loose lips sinks ships.
Good news!
Has the commitment changed in the Philippines?
She isn’t shown on the team anymore on the cydy website, and her LinkedIn profile no longer has any reference of Cytodyn.
Is Arian Colaches still at Cytodyn?
Who is Paul?
Yes, trial required.
Frederic Hayden from CD12 DSMB quoted here: https://www.statnews.com/2020/04/29/gilead-says-critical-study-of-covid-19-drug-shows-patients-are-responding-to-treatment/
Shareholder petition?
I see. So if the funds don’t go to inventory, then where are they going? I’m afraid I have to agree that Nader has to step down. When we can’t rely on his information, press releases, video interviews, and the bridges with FDA are burned he does not bring anything to the table any more. Borrowing money at 10% to pay debt service at 10% over and over just consumes all shareholder equity in the end. I don’t think we ever have gotten a straight answer on what the problems and delays in the HIV BLA were or are. If anything we need truth and honesty and integrity in a CEO.
Not to mention FDA’s hostile placement, Dr Frederic Hayden from GILD on the CD12 DSMB
That needs to be tweeted in response to FDA’s statement about Leronlimab on Twitter. It is very sad and shows that FDA is criminally malevolent towards CYDY and all Americans who died in CD12 and since. Hayden should lose his medical license and be tried for murder.
“ The FDA release was actually exciting news for Cytodyn. This will bring enormous publicity to leronlimab. We are definitely a triple digit stock. EUAs and purchase orders are in the pipeline, we have so much interest from all around the world, and we have fight off acquisition offers from big pharma with a crowbar. Let talk to you about my mother-in-law...”
FDA “advice” and restrictions on dosing set Leronlimab up for failure in CD10 and CD12. To hell with FDA. Brazil trials and India trials will show FDA for the crooks that they are.
A deal was signed and PR’d with Chiral already.
Interesting.