Replies to post #132605 on Anavex Life Sciences Corp (AVXL)

[jimmy667]

Probability of A2-73 being approved for ANY CNS Indication would depend in a large part on the Trial Designs and FDA agreed on Endpoints and any Special Protocols.

I see you asked this question twice and got no response. However, you provided some rather sound analysis yourself. Which is good because a question such as yours is one each must answer for themselves. However, I found your post helpful and enlightening.

If FDA agrees that A2-73 could be approved by reaching intermediate endpoints for symptomatic relief such as Relief from Insomnia, Improvement in Mood, Irritability and Agitation and other symptoms short of the harder to reach ultimate goals of slowing or reversing decline in cognition and memory then knowing what we know and if these findings play out in the larger trial then one would think the chances for approval of A2-73 are excellent. Symptomatic relief alone would make A2-73 a blockbuster drug.. The bar for approval is set low.

Of course, the trials and research into the penultimate goals of cognition and memory would continue. A2-73 might be approvable on the intermediate symptomatic endpoints it all depends on what the FDA agrees on as the various endpoints.

Market participants might be waiting to see what these endpoints will be, this is why the trial starts might be a catalyst, not the starting of the trials per se rather the disclosure of the Trial Designs and FDA Approved Endpoints for A2-73 approval.

Other posters started this thread yesterday where I replied thus:

Potentially HUGE near-term catalyst for A2-73 development as well as stock price was recently illuminated by Mrplmr and Bourbon in this thread of posts:
Quote:
Bourbon_on_my_cornflakes Thursday, 11/30/17 01:48:12 PM
Re: mrplmer post# 132419
Post #
132420
of 132518 Go
"Authority under FDASIA to grant accelerated approval based on intermediate clinical endpoints"

hmm, could insomnia prevention be an intermediate clinical endpoint for alz? you would know that in 3 months!


Take a moment to ponder the gravity of this particular point. Some have opined that the start of the trials will not be a stock moving event. Of course, these are expected. If they start before end of the year there may be some relief rally to the extent that delay was baked into the recent slide. However that is not the point!

The point is the unveiling of the Trial Designs together with the FDA agreed endpoints particularly the Alzheimer's P2/3 design and plan.

Now if the FDA agrees that there are intermediate endpoints that could be reached that would provide immediate and safe relief to Alzheimer's victims, such as relief from insomnia, agitation, mood and other symptomatic benefits short of the penultimate goal of preventing (or slowing) decline of cognition and other traditional and hard to reach endpoints what would the New FDA be mandated by the 21st Century Cures Act to do?

How would this speed the development of A2-73?

How might the Market react to this highly achievable intermediate approval scenario?

I know many of you have carried a heavy risk load for a long time. Hang in there the reward may come in the next three weeks.

Good Luck to all Honest Longs.

On another note,

I think you are right on the TD Sequences, it looks like a marginal 8 Friday on the set-up on daily chart so we could see the 9 on Monday. AVXL seems to reverse on the 9 set-ups and not wait for the 13 countdowns. It flipped on a 9 setup 10/24/17 to reverse into the slide we are in now. So maybe we will get a reversal just in anticipation of news but it would seem any good news will start the reversal.

Thank you for all your great posts Sokol.

Good Luck to all Longs!

Go Anavex>>>>>>>>