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Re: None

Thursday, 12/08/2022 10:31:54 AM

Thursday, December 08, 2022 10:31:54 AM

Post# of 461414
If I had to guess what is going to happen next is with the current P2/3 data set which has met its primary and secondary endpoints I would do the following: I would take that data and package it up for an NDA with Accelerated Approval, in ALL the country agencies ( FDA, TGA, EMA, etc. ). I would include within the NDA all the data from the previous PDD and Alz trials along with all the OLE data. That OLE data has been promised this month as you recall. I will make the assumption that we will get that as promised. If they can get the NDA out before the end of the year or Jan/Feb of next year and they announce it, the stock will skyrocket. Once the agencies accept the documents for review the stock will rocket some more. Not sure how long they have to either accept or deny such a request but regardless just the submission and there is only one way to go, and that is up. Follow that up with Rett P3 data and soon to follow Accelerated Approval for that NDA submission and now we are really cranking. Hopefully we get Rett approval first to collect the voucher and we use that to further expedite the Alz NDA. Maybe just maybe we have both indications on the market before the end of the year or Q1 worst case. Am I dreaming??
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