I think this is happening at the perfect time (alt
Post# of 154809
(Total Views: 785)
Posted On: 06/29/2020 7:00:23 AM
I think this is happening at the perfect time (although I would have appreciated it happening a month ago).
Not sure why we lost a month, makes no sense. However, this possibly supports the thesis that the FDA told either CytoDyn or Mexico to not start a trial until the US S/C was over. As of yesterday, the S/C has to have concluded. The curious timing of this announcement is just a bit too suspicious for me.
I, too, think it will be enrolled in a snap. I can't imagine they are still hammering out a protocol that was submitted and translated around a month ago. So, I would think it's just a matter of enrollment, and sadly, I'm guessing Mexico has no shortage of willing participants.
I will take any and all leverage to force the FDA to do the right thing, as they have proven themselves to not be a trustworthy regulatory agency.
Frankly, I view this as a very significant de-risking event. All we have to do is wait 6-8 weeks and Mexico is going to approve leronlimab using more relaxed standards than the US FDA. And if the US FDA doesn't do the right thing, our inventory will be sold to Mexico and any other Latin American country that accepts the Mexican approval.
Not sure why we lost a month, makes no sense. However, this possibly supports the thesis that the FDA told either CytoDyn or Mexico to not start a trial until the US S/C was over. As of yesterday, the S/C has to have concluded. The curious timing of this announcement is just a bit too suspicious for me.
I, too, think it will be enrolled in a snap. I can't imagine they are still hammering out a protocol that was submitted and translated around a month ago. So, I would think it's just a matter of enrollment, and sadly, I'm guessing Mexico has no shortage of willing participants.
I will take any and all leverage to force the FDA to do the right thing, as they have proven themselves to not be a trustworthy regulatory agency.
Frankly, I view this as a very significant de-risking event. All we have to do is wait 6-8 weeks and Mexico is going to approve leronlimab using more relaxed standards than the US FDA. And if the US FDA doesn't do the right thing, our inventory will be sold to Mexico and any other Latin American country that accepts the Mexican approval.
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