"...the FDA will already be familiar with the tria
Post# of 155140
(Total Views: 638)
Posted On: 01/29/2021 4:49:56 PM
"...the FDA will already be familiar with the trial results and won't need to take time to go over Amerex's report.
No, going over the Amarex report is exactly what the FDA will be doing. The CRO generates the Trial Master File that is officially archived for future reference and is what is unblinded when Cytodyn accesses it.
What is great and time saving is that the FDA isn't requiring any further presentation nonsense. The Amarex report can speak for itself. FDA analysts are perfectly capable of understanding what it proves about LL and whether LL should get EUA and advance thru the rest of the process for approval and sale.
The FDA and Cytodyn will know what is in the TMF at the same time. I believe the usual case is that the sponsor sends the data to the FDA and asks them to look at it. The FDA does not normally ask for the data.
That the FDA is asking for the data is a very good sign indeed. They are looking to save time too - very unusual. This is about the first sign of urgency we have seen out of them besides allowing Cytodyn to got to the CD10 and CD12 trials after early eIND evidence.
News of sales and urgency should jack up the stock price!
No, going over the Amarex report is exactly what the FDA will be doing. The CRO generates the Trial Master File that is officially archived for future reference and is what is unblinded when Cytodyn accesses it.
What is great and time saving is that the FDA isn't requiring any further presentation nonsense. The Amarex report can speak for itself. FDA analysts are perfectly capable of understanding what it proves about LL and whether LL should get EUA and advance thru the rest of the process for approval and sale.
The FDA and Cytodyn will know what is in the TMF at the same time. I believe the usual case is that the sponsor sends the data to the FDA and asks them to look at it. The FDA does not normally ask for the data.
That the FDA is asking for the data is a very good sign indeed. They are looking to save time too - very unusual. This is about the first sign of urgency we have seen out of them besides allowing Cytodyn to got to the CD10 and CD12 trials after early eIND evidence.
News of sales and urgency should jack up the stock price!
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