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Posted On: 01/18/2022 2:28:23 AM
Post# of 145873
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Has anyone brought up the subject of the meta analysis that recently came to light? Who asked for it? Cytodyn or did Cytodyn tell the FDA that some trial or Leronlimab use somewhere is doing really well and Leronlimab is showing good efficacy. Then did the FDA say… well if that’s the case then we will allow you to combine trials to get p value strength like we needed all along.
Then Nader said FDA would allow our Brazil trials also in the meta analysis. Nader then told us we were asking Anvisa soon if they will do the same.
The question is why now? Where is this coming from? Could this be the anecdotal Philippines patients driving this? Is this the same as saying… anecdotal don’t just come off life support?
I would like to hear some opinions on where we think this might be coming from. Because this sounds like the FDA is ready to finally help us. Did the mTNBC trial and the anecdotal 350mg Nash open trial results wake up the FDA and we finally have them in our corner and trying to help us? Could this be to good to be true? Am I dreaming? Should I pinch myself?
What does everyone think about this?
I apologize in advance if this subject has been brought up and I missed it.
Then Nader said FDA would allow our Brazil trials also in the meta analysis. Nader then told us we were asking Anvisa soon if they will do the same.
The question is why now? Where is this coming from? Could this be the anecdotal Philippines patients driving this? Is this the same as saying… anecdotal don’t just come off life support?
I would like to hear some opinions on where we think this might be coming from. Because this sounds like the FDA is ready to finally help us. Did the mTNBC trial and the anecdotal 350mg Nash open trial results wake up the FDA and we finally have them in our corner and trying to help us? Could this be to good to be true? Am I dreaming? Should I pinch myself?
What does everyone think about this?
I apologize in advance if this subject has been brought up and I missed it.
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