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Posted On: 11/10/2021 1:24:32 PM
Post# of 148863
Hi Gestalt,
My biggest failing in my DD re: CYDY has been Amarex. I assumed they were a top quality company for doing the BLA.
Long after we were having BLA issues, I did the DD that I should have done previously. What I found out is that Amarex is not a BLA company. They are a CRO that focuses almost exclusively on the early stage the the drug development process -- not the latter stage.
They are very experienced at that early stage and have gotten many protocols submitted and approved by the FDA. But if you look at their history for the ~past 10 years, they have very few (2 if I recall correctly BLAs submitted and at least one was for a simple medical device).
They certainly didn't have the background, experience, or "resume" to be leading our P3 trials and BLA submission.
My biggest failing in my DD re: CYDY has been Amarex. I assumed they were a top quality company for doing the BLA.
Long after we were having BLA issues, I did the DD that I should have done previously. What I found out is that Amarex is not a BLA company. They are a CRO that focuses almost exclusively on the early stage the the drug development process -- not the latter stage.
They are very experienced at that early stage and have gotten many protocols submitted and approved by the FDA. But if you look at their history for the ~past 10 years, they have very few (2 if I recall correctly BLAs submitted and at least one was for a simple medical device).
They certainly didn't have the background, experience, or "resume" to be leading our P3 trials and BLA submission.
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