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Re: None

Monday, 09/16/2019 11:20:12 PM

Monday, September 16, 2019 11:20:12 PM

Post# of 458322
The Rett P2 study is much better constructed than the Alz P2 study. I feel that the Rett data points released today are near bullet proof - and could be used for black box or expedited approval.

I am still, however, reserved that this matters for approval (despite agreeing that 'yes, A27-3 completely works') because of AVXL's Alzheimer struggle they have endured since November 2014 (a month that will go down in infamy!)

And despite the data points, we are seemingly no closer for Alz than we were 5 years ago.

So, does A27-3 work? Yes. Clearly. Such tight tolerances of P=0.003, and a 50 to 34 point improvement means there is no room for discussion. A27-3 works. hands down. But despite the exuberance, a Rett P3 will not be complete until Summer 2020. Which won't be marketable or FDA approved until Q4 2020 or sometime in 2021. If the data continues to be presented like it has been, maybe we'll tick to $4, or even $5, but if we ever see $10 again before 2021 it will be very unexpected (by me at least).

So the variable is do we get early approval for Rett, or not? I want it to be yes, but seeing how Alz is going, I think nothing will be rushed to approval, despite the logical reason that A27-3 should be.
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