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Re: A deleted message

Monday, 10/15/2018 1:21:42 PM

Monday, October 15, 2018 1:21:42 PM

Post# of 403047
No you did not miss anything. FDA prefers to have BTD application before successful (important distinction) end of phase 2 meeting, otherwise most of the benefits of BTD are lost for applicant. And because FDA does not see BTD providing much, if any, benefits to company past phase 2 it might even decline to issue it after successful end of phase 2 meeting.

So logically, if applying for BTD, even only for marketing reasons (ala Galera:phase 2 trial --> BTD --> end of phase 2 meeting --> phase 3; nil intended benefits from BTD to Galera) gets delayed what does company do with application for end of phase 2 meeting? Goes ahead and squanders bragging rights for BTD. I don't think so.

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