Sunday, October 03, 2021 9:40:34 PM
You bring up very valid points..as to the RTF issued by the FDA..For our HIV BLA..!!!
In the over 140 Clinical Trials I have participated in..!!!
Never has the CEO of the Sponsor checked the Adverse Effects of ANY PATIENTS..!!!
Never been involved in checking Data Basis..Demographics..Subpopulation Analysis..!!!
Yet..!!!
Pfizer..Regeneron..Eli Lily seem to get their drugs approved..??
Could it be..!!!
That the CRO conducting their studies..Responsible for the issues listed in the RTF..Were competent..??
That these CEO’s used Legit vendors..For tasks requested by the FDA..???
Asking for a friend..!!!
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