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BonelessCat

10/15/18 1:29 PM

#244907 RE: PlentyParanoid #244904

You are misinterpreting the purpose of a BTD. Ideally it is before the end of phase 2 meeting because there is little or no benefit from a BTD approval once phase 3 is approved to start. An approved BTD after the end of phase 2 meeting would require a new meeting and resubmission of the trial design, thus eating any time advantage gained by a BTD.