It is an assumption on my part that the FDA is tel
Post# of 154720
(Total Views: 658)
Posted On: 06/03/2020 11:31:53 AM
It is an assumption on my part that the FDA is telling Cytodyn that they do not need to finish either trial completely, but it is based on what Nader said and what Dr J confirmed. They were quite clear that they are presenting the data to the FDA on 6/15 no matter where they are in the trial and that they are not going any further in getting more patients beyond that date, for the M2M trial.
There is no rational reason why they would state this other than they are confident the FDA wants the data ASAP when they have 14 days from injection on the patients on 6/15. Cytodyn could easily state they will just give a readout on 6/15 but will also continue to recruit, they could also not give out the 6/15 date at all. There is some very solid reason for this hard date and I feel it is born out of discussions with the FDA and the data they are already seeing.
Keep in mind, the FDA is watching dozens of drugs for treating covid, only one has years of safety data in over 800 patients showing no side effects, Leronlimab. The FDA's biggest fear is approving a drug that does not work and causes so many terrible side effects that it is worse than the disease. Their day to day job is deciding if the side effects are worse than the benefit on almost every drug they are evaluating in every indication. For them, a drug with this much safety is the one they most want to approve. All they need is data to show it actually works.
There is no rational reason why they would state this other than they are confident the FDA wants the data ASAP when they have 14 days from injection on the patients on 6/15. Cytodyn could easily state they will just give a readout on 6/15 but will also continue to recruit, they could also not give out the 6/15 date at all. There is some very solid reason for this hard date and I feel it is born out of discussions with the FDA and the data they are already seeing.
Keep in mind, the FDA is watching dozens of drugs for treating covid, only one has years of safety data in over 800 patients showing no side effects, Leronlimab. The FDA's biggest fear is approving a drug that does not work and causes so many terrible side effects that it is worse than the disease. Their day to day job is deciding if the side effects are worse than the benefit on almost every drug they are evaluating in every indication. For them, a drug with this much safety is the one they most want to approve. All they need is data to show it actually works.
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