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Posted On: 12/13/2018 6:39:30 PM
Post# of 72440
This is interesting. I’m sure I read it before but must have been daydreaming...
“Barring a significant scientific development that requires otherwise, studies conducted in accordance with the agreement [for Phase 3 trial] shall be presumed to be sufficient in objective and design for the purpose of obtaining marketing approval for the drug.”
“Barring a significant scientific development that requires otherwise, studies conducted in accordance with the agreement [for Phase 3 trial] shall be presumed to be sufficient in objective and design for the purpose of obtaining marketing approval for the drug.”
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