NP found the subgroup where LL showed merit. That is all. If you think that criteria that define that subgroup are inadequate or defective, then make the case for that by pointing out the details; otherwise it is well and good that he found it, designed the next trial based on it, and ANVISA approved that trial based on their own assessment of cd12 and Cytodyn's explanations. The fact ANVISA approved it as we wanted is a big statement for many of us regarding their assessment of cd12 data, though not for you based on your ideas on how/why phase 3 gets approved.
The words you use, "manipulate" and "misrepresent" of the clinical subgroup, where is the proof? If you are simply going to quote the FDA letter like it is scripture or God, then I cannot say much about it further rationally. Others think the FDA is misrepresenting what Nader said. I saw what Cytodyn said of cd12 data and its critical subgroup, and I have written about it as well to the extent I understood the data and the mathematics. I don't see any misrepresentation or manipulation there. The numbers are what they are; and they are positive. No one said, positive enough for full approval by the regular process, though investors hoped for EUA in a pandemic, based on lesser data or through other assessments. It is not illegal to hope this or to ask the FDA whether the data merits an EUA - I don't recall if Nader said after cd12 that we are going to even ask for EUA. All I heard was emphasis on the promising critical subgroup data, but it was clear to me that it was not SS and we had more work to do.
Here is what my first assessment of the cd12 PR of Cytodyn was:
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