Meanwhile, a treatment with ZERO SAE's in over 800
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And isn't it touching that the same "best people"--who had accepted remdesivir as a "new standard of care" and didn't say a word when the HQ was announced as the solution to Covid-19--finally got religion and now cared only about "science"? To the extent that they "recommended" Cytodyn against applying for compassionate use BECAUSE it could slow down our enrollments and be detrimental to the progress medical science! When I first heard about this from Dr. Pourhassan I felt ashamed because of my cynicism about the FDA and my silly (to say the least!) "conspiracy theories" about our democratically elected leaders and their appointees. But then I asked myself again: Why Dr. Lalezari sounded so pissed off with the FDA when they twice rejected his request for Compassionate Use back in early April. I also asked myself what happened to the rest of those 400 sick people who were screened by Novant and were denied participation in the trials because they apparently did not satisfy all "scientific" parameters of the studies? How did they do, those 380 or so? Now in the light of these questions I am no longer sure I must be ashamed of my suspicions about the "best people." Perhaps, I got to go back to square one of my thinking about them-- the imperative of deniability. If the FDA granted us the compassionate use, this would immediately and significantly increase our visibility and hopes for the cure. If the FDA formally denied our request this could raise questions later, especially in the scenario of leronlimab's eventual success and recognition. This is a no-no for the principle of deniability. So instead they gave us a friendly advice not apply for compassionate use ... for the sake of "science" and our best interests. Off the record. With the best intentions of the "best people."
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Le-Ron-Li-Mab, and they have not.