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Re: PhrmaBro post# 173480

Wednesday, 07/07/2021 10:54:23 PM

Wednesday, July 07, 2021 10:54:23 PM

Post# of 232969
Thanks. That does make the system clearer. SEC was correct in calling out Cytodyn for tagging "clinically proved" based "solely on the results of our clinical trials". I probably read too much into Cytodyn's statement on FDA not asking or commenting about the science of LL; it only means that the RTF is not a black-mark directed at our science - the same trial data suffices and we can fill in the gaps.

For longs, we should anticipate that Cytodyn will correct the deficiencies and complete the BLA filing again. But that is still the first step. FDA then has to affirm safety and efficacy from the data in their full review.
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