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i think the FDA's explanation or backup to show why they have such a negative opinion is very important because it is very possible a lawsuit against the FDA could be justified. If I was the CEO and this is how the FDA was treating the situation, I would make it very clear that until the FDA gives the clarity on to what this is based on there should be no money wasted on trials etc..

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We know from Cytodyn's own analysis of the data dumps from Amarex that we got that the data was a complete mess. That only a few things needed to be cleaned up after the last BLA submittal is BS. Amarex was struggling for nearly a year to fix the initial submittal of the BLA because their original data collection was awful. That Cytodyn post Nader would have to collect the raw data from trial sites tells the whole story. So, yes Amarex is fully on the hook for their disastrous performance.

That the FDA screwed us on the Covid-19 trial is squarely on the shoulders of the FDA.