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Posted On: 05/20/2021 12:53:21 PM
Post# of 148899
It is difficult to know at this point other than those who in the room when these discussion occurred. Hindsight is always 20/20, but it never occurred to me that patients would not receive leronlimab for the 2nd half of the trial until CD12 results were published. I have no background in trial designs or these things, but you would think that Amarex or CYDY would’ve fought hard to ensure they were not handicapped from the beginning. Granted, many eIND patients recovered with only 2 doses, so maybe they thought they had a homerun regardless, but obviously that isn’t how CD12 played out. Looking back it is easy to see the blunders that were made (4 doses, properly stratified, age adjustments, easier PE, proper randomization….if 2/5 of these were done properly CD12 likely would’ve received an EUA).
I don’t know if you recall, but the original CD12 trial design submitted was 2 doses with 14 day PE. Whoever pushed to extend to 28 days, should’ve also been pushing for active drug for the duration of the PE.
https://www.cytodyn.com/newsroom/press-releas...the-fda-to
At this point, it doesn’t matter. All I want to see is international trials being initiated and some CSP sales in the interim.....and I believe the share price appreciation will follow.
I don’t know if you recall, but the original CD12 trial design submitted was 2 doses with 14 day PE. Whoever pushed to extend to 28 days, should’ve also been pushing for active drug for the duration of the PE.
Quote:
Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 14 days.
https://www.cytodyn.com/newsroom/press-releas...the-fda-to
At this point, it doesn’t matter. All I want to see is international trials being initiated and some CSP sales in the interim.....and I believe the share price appreciation will follow.
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