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Tuesday, February 22, 2022 11:49:39 AM
Prudent management would keep from making any claims on anything after that, as they will eventually need the FDA to approve certain applications for the drug in the US.
Quite the big deal about the proactive in question, which was about the start of trials in Brazil to prove efficacy in treating critical and severe Covid. This is the very thing that was called out in this letter and shows that some at the FDA are afraid that they will be outed for killing a Covid treatment and seem to be attempting pressure on Cytodyn about ever claiming covid efficacy.
It appears that Cytodyn will wait until interim numbers are enrolled and topline results are available to refute the claims in this letter which are about CD10 and CD12.
Until that time, they will not comment on any trial results or make any claims about Leronlimab, there may or may not be a partnership in the wings or a buyout. If there is anything, it will hinge on removing this blemish which I feel is BP driven and within the bounds of the FDA mission at this point but also motivated by outside influence on the FDA.
So at this point all movement forward will depend on removing this blemish caused by NP's unbridled enthusiasm and forward statements.
We now know why LH trials are in limbo, my hope is that Brazil knocks it out of the park gets an EUA there an in other foreign countries, gets the clue that the US is a snakepit and concentrates Trials outside the US until they get massively larger.
JMO
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