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Posted On: 08/28/2020 11:20:10 AM
Post# of 148892
Sure - several quick examples of what I view as unreasonable FDA action.
My issues with FDA have always been related to combo HIV trial. I extrapolate the rest (i.e., if it has happened before, it likely is happening again).
That said, as I said in my post, my personal belief is that it is a negative feedback loop where both factors (FDA, etc., management inexperience/lack of connections) play off of each other to the detriment of CYDY, its shareholders, and patients.
1) Based on past company statements, the FDA forced CYDY to do a combination therapy trial as a condition to even allowing CYDY to explore a monotherapy HIV indication for leronlimab.
2) As a result of having to do a combo trial, CYDY spent time and resources enrolling a difficult trial to enroll (due to exclusion criteria) that could have been spent developing and pursuing a far-more lucrative monotherapy indication.
3) CYDY hit PE in the combo therapy HIV trial at 350 mg two and a half-years ago with a p value of .0032 and twice the efficacy of maraviroc (a Pfizer drug). Safety data for 350mg would have been available shortly thereafter.
4) It appears (based on company statements) that the FDA forced CYDY to file combination therapy BLA at 700 mg rather than the 350 mg at which the trial was run, which required extensive new safety data. Due to FDA requiring 700 mg and extensive new safety data, and the accompanying CMC/stability data for 700 mg, the BLA was delayed extensively.
Plenty of people still die every year due to HIV resistance complications, while leronlimab sits on the shelf unapproved
https://www.cytodyn.com/newsroom/press-releas...in-pro-140
My issues with FDA have always been related to combo HIV trial. I extrapolate the rest (i.e., if it has happened before, it likely is happening again).
That said, as I said in my post, my personal belief is that it is a negative feedback loop where both factors (FDA, etc., management inexperience/lack of connections) play off of each other to the detriment of CYDY, its shareholders, and patients.
1) Based on past company statements, the FDA forced CYDY to do a combination therapy trial as a condition to even allowing CYDY to explore a monotherapy HIV indication for leronlimab.
2) As a result of having to do a combo trial, CYDY spent time and resources enrolling a difficult trial to enroll (due to exclusion criteria) that could have been spent developing and pursuing a far-more lucrative monotherapy indication.
3) CYDY hit PE in the combo therapy HIV trial at 350 mg two and a half-years ago with a p value of .0032 and twice the efficacy of maraviroc (a Pfizer drug). Safety data for 350mg would have been available shortly thereafter.
4) It appears (based on company statements) that the FDA forced CYDY to file combination therapy BLA at 700 mg rather than the 350 mg at which the trial was run, which required extensive new safety data. Due to FDA requiring 700 mg and extensive new safety data, and the accompanying CMC/stability data for 700 mg, the BLA was delayed extensively.
Plenty of people still die every year due to HIV resistance complications, while leronlimab sits on the shelf unapproved
https://www.cytodyn.com/newsroom/press-releas...in-pro-140
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