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Posted On: 03/22/2021 11:38:39 PM
Post# of 148903
Re: ClosetInvestor #83966
You're wrong, CI. Drug companys have anything but a free hand in the development of trial protocols where human subjects are involved. Safety comes first.
The Center for Drug Evaluation and Research (CDER), a huge part of FDA, OKs all drug protocols and, over time, has gotten more and more involved, not just to meddle but to give guidance to save everyone's time and expense but especially to protect the participants in drug trials.
A simple Google search on "Drug Trials CDER" turns up many guideline documents from the FDA with almost yearly pushes to improve trial results. Here's one that pertains to Cytodyn - "FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic - Guidance for Industry, Investigators,and Institutional Review Boards."
"Because of the complexity of these trials and the potential regulatory impact, it is important that such trials are well designed and well conducted to ensure patient safety and to obtain quality data that may support drug approval."
The FDA may not choose primary and secondary endpoints for a trial sponsor but they have lots of opinions about how trials should be conducted - protocols. And the FDA knows what it is looking for as far as treatments and cures are concerned, especially with this concept of theirs that the whole Pandemic is like a pie or a puzzle and everyone should concentrate on their slice or piece.
And that's why we were turned down for Mild/Moderate even tho Leronlimab could treat that population just fine. They force Cytodyn towards the Severe/Critical piece when no one even knew what that meant. They approved the protocol for CD10 and CD12, approved the trial sizes and then started moving the goal posts and adding more hoops to jump thru.
I'm not entirely critical of the FDA for doing that but it is a little hard on a small, no revenue company. They should make it up to Cytodyn for jerking them around and not giving them better guidance. Playing the "Whose to Blame" game doesn't get us approval. And Nader is right not to take the "damn torpedoes approach". Good on him!
Cytodyn's team is a good team and they know a lot that we don't know so I trust their judgement to make the best calls, not always the right calls. I am thankful for their concern for shareholders, which is not often the case in my experience. I think we just have to be patient with the process.
My best hopes are with the MHRA. I think they may surprise us the soonest.
The Center for Drug Evaluation and Research (CDER), a huge part of FDA, OKs all drug protocols and, over time, has gotten more and more involved, not just to meddle but to give guidance to save everyone's time and expense but especially to protect the participants in drug trials.
A simple Google search on "Drug Trials CDER" turns up many guideline documents from the FDA with almost yearly pushes to improve trial results. Here's one that pertains to Cytodyn - "FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic - Guidance for Industry, Investigators,and Institutional Review Boards."
"Because of the complexity of these trials and the potential regulatory impact, it is important that such trials are well designed and well conducted to ensure patient safety and to obtain quality data that may support drug approval."
The FDA may not choose primary and secondary endpoints for a trial sponsor but they have lots of opinions about how trials should be conducted - protocols. And the FDA knows what it is looking for as far as treatments and cures are concerned, especially with this concept of theirs that the whole Pandemic is like a pie or a puzzle and everyone should concentrate on their slice or piece.
And that's why we were turned down for Mild/Moderate even tho Leronlimab could treat that population just fine. They force Cytodyn towards the Severe/Critical piece when no one even knew what that meant. They approved the protocol for CD10 and CD12, approved the trial sizes and then started moving the goal posts and adding more hoops to jump thru.
I'm not entirely critical of the FDA for doing that but it is a little hard on a small, no revenue company. They should make it up to Cytodyn for jerking them around and not giving them better guidance. Playing the "Whose to Blame" game doesn't get us approval. And Nader is right not to take the "damn torpedoes approach". Good on him!
Cytodyn's team is a good team and they know a lot that we don't know so I trust their judgement to make the best calls, not always the right calls. I am thankful for their concern for shareholders, which is not often the case in my experience. I think we just have to be patient with the process.
My best hopes are with the MHRA. I think they may surprise us the soonest.
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