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Re: loanranger post# 241785

Wednesday, 09/19/2018 1:08:07 PM

Wednesday, September 19, 2018 1:08:07 PM

Post# of 403047
Little clarification, FDA has made it pretty clear that it prefers to get BTD request in before end of phase 2 meeting for the same drug. And, FDA can reject or grant a request for end of phase 2 meeting regardless what happened to BTD request - they are substantially different requests.

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