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Message: Breakthrough Therapy Question

I wasn't really "wanting" any particular response.....however my preference would have been to learn that one of or both of the FDA/EMA were in receipt of an application for Breathrough Therapy Status.

To answer both you and Koo, I'm inferring from their answer that the application is not yet in the hands of the FDA/EMA.  Further I'm expecting it to be disclosed once it happens, if it does in fact happen. 

I'm remembering well our expectation of a Futility Analysis and then a SSRA....both times nothing was said before hand to lead us to believe they would not happen....but as we all know now, neither was conducted.  

Similarily now we're all waiting on news (I am in any event) that an application for BTS has actually been submitted...but if they decide for some reason not to submit one I don't expect we'd be notified until after the fact.  

 

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