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Posted On: 10/16/2020 12:02:23 AM
Post# of 155610
Ohm20,
The FDA guidance for clinical sponsors indicates that the guidance is not binding (as much of what the FDA has done lately seems not to be bound by an rules).
Your thoughts on Dr. Seethamraju's statement that DSMB and FDA were evaluating unblinded data?
The FDA guidance for clinical sponsors indicates that the guidance is not binding (as much of what the FDA has done lately seems not to be bound by an rules).
Your thoughts on Dr. Seethamraju's statement that DSMB and FDA were evaluating unblinded data?
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