Replies to post #137222 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

Some people perhaps will fully appear stuck on old thinking. This has always bee and will always be a recipe for failure.

[jimmy667]

I believe Anavex can go for a something like a "rolling approval" in ALZ by first showing insomnia and mood improvement. Recieve approval for that then following these patients and measuring other improvements in those patients as well as the ones formally in the trial to support an expanding label for A2-73 if other improvements are seen beyond the symptomatic improvements in sleep ,mood and others symptoms.
Make in effect a trial that started with a small n into one of a large n by following patients taking A2-73 Phase 4 style.
A limited label for symptoms only would make A2-73 a major blockbuster and provide much relief from suffering for ALZ victims and their caregivers.

I believe the language of the FDA you quoted supports this.

Take a guess what might happen to AVXL stock price when it is announced that the FDA agreed with such a plan and Anavex announces that is how they will proceed.
Long Anavex.

[kevindenver]

Boom, the "no duh" clause finally added to a bureaucratic agency. LOL!

IMO these structural changes by the FDA will great for all biotech.
Bet we see lots of M&A activity in 2018, all that fresh repatriated cash from the tax bill is going to burn a hole in someone's pocket!

Why invent it when I can just buy it? Odd undulations are going to go down in this sector.

Hopefully AVXL benefits. ;)

[tredenwater2]

Great posts Nidan. This may be very well what we are waiting on. Gottlieb is rolling out in slow motion the new guidances so BP has the time to get out of its own way.

Will these guidance's apply to trials done outside of the USA. Specifically our PD trial. IF it shows symptomatic relief in PD, like possibly Rett, will the FDA revue the data and act on it in the US?

Great things lining up, just taking time.

Tred