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Re: None

Thursday, 11/16/2017 12:10:36 PM

Thursday, November 16, 2017 12:10:36 PM

Post# of 462058
Well, now what?

My guess is we soon find out what and how much homework/prep has been done while we waited for this FDA PR step 01. A very quick read suggests the 3rd party sponsors for Rett/AD/PD will be ready to engage. The FDA guidance suggests this 3rd party pre-work is key to kicking the accelerated process off. Considering the pre clinical/clinical trials work already available we should see IND PR to follow as an AVXL SAB/3rd party team effort has been ongoing. I expect joint FDA PR on risk-benefits-time line analysis and would not be surprised to see BTD.

These may seem like leaps but I believe most/much of the trials prep has been done and the usual timelines will not apply. We'll see.
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