Misrepresenting a drugs efficacy is a significant public interest. FDA Statement was to notify the public that the company's filings and communications misrepresenting and manipulating the CoV trial data.
There were false and misleading statements -- CD10 NEWS2 was claimed to have met the endpoint -- it didn't. The CD12 post hoc data dredged critical subgroup was repeatedly reported a significant and it was not -- company did not use appropriate statistical analysis.
FDA reviews the protocol and the data as compared to the specified endpoints. That's what counts. The CD10 and CD12 failed to meet ANY trial endpoints. No other subgroups count other than to inform future trials.
They have four M2M therapeutics currently. Cytodyn has stated they plan on doing a U.S. Critical CoV trial. Brazil was intended for Brazil EUA approval according to NP. He did not file an U.S. IND or have an FDA audit for Brazil so will likely not be eligible for U.S. consideration.
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