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runncoach

02/08/18 6:18 AM

#5717 RE: Whoopddew #5716

That's a good question. One company in particular that got the designation in October was using p1/2a data on a population less than 20 that did not show cognitive efficacy, simply met some of their bio marker testing parameters at the 4 week mark, so yes it would be possible in designing of this trial I suppose. My guess is they will design with FDA oversight and a discussion of where next to go as expeditiously as possible based on the confirmation results and at that point get the designation, but that's a big guess. If it comes soon as they set this trial up, IMO and others I have talked with, it could be a big share price mover.
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Wildginger

02/09/18 10:02 AM

#5718 RE: Whoopddew #5716

After listening to the Q and A one of the questions was what dose was CU patients given and Alkons response was the higher dose. Can someone explain since the 40 clearly didn’t work in the last trial.