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PlentyParanoid

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PlentyParanoid

Re: loanranger post# 246268

Thursday, 10/25/2018 10:16:52 AM

Thursday, October 25, 2018 10:16:52 AM

Post# of 403047
LR, BTD was intended to speed up the early clinical stages of drug development without changing drug approval requirements. The last step where FDA can and will help a sponsor with BTD is the design of phase 3 trial. After that FDA is back to its usual gatekeeper duty.

"I would rather have questions that can't be answered than answers that can't be questioned." Richard P. Feynman

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