How do you know that Amarex was not responsible fo
Post# of 153993
(Total Views: 728)
Posted On: 01/15/2022 11:31:09 PM
How do you know that Amarex was not responsible for correcting the Receptor Occupancy issues? As CRO they were over seeing the trial and preparing the BLA. They were told by the FDA that the RO from Patterson (uncertified) were not acceptable and it was listed as a change needed on the list of issues with the BLA and most were not addressed or corrected.
It seems you are thinking that maybe Nader decided to take on this duty himself. I would be willing to bet that Dr Kush (PHD) whatever his last name was took care of any issues as the active trial CRO in charge or was part of the paid team put forward by Amarex to take care of issues. Somehow clinical corrections did not get completed now did they. Amarex was responsible for just about everything as our paid consultant and CRO.
It seems you are thinking that maybe Nader decided to take on this duty himself. I would be willing to bet that Dr Kush (PHD) whatever his last name was took care of any issues as the active trial CRO in charge or was part of the paid team put forward by Amarex to take care of issues. Somehow clinical corrections did not get completed now did they. Amarex was responsible for just about everything as our paid consultant and CRO.
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