Replies to post #132325 on Anavex Life Sciences Corp (AVXL)

[Fireman02360]

I believe them...

I do too, Mike. The hiring of Dr.Fadrin is also telling. This move by Anavex/Missling gets little attention but this move was a HUGE. Who else would you rather have doing the trial filings and help with trial design than a major FDA player? I also believe that Dr. Gottlieb would not shut-down a whole industry waiting for him to announce new guidance. I truly believe the FDA is providing assistance to those biotech companies that are ready to start trials. To assume otherwise is ridiculous. That's like saying the VA would stop treating vets/patients while they restructure the agency. Ridiculous.

-Fireman

[jimmy667]

We know the new FDA 21st Century Cures Act CNS guidence will come before end of year. These could be announced any day and may be announced during trading hours.
It is more unclear if they will directly reference A2-73.
But it does seem likely that Anavex is just waiting for the FDA announcement of the 5 CNS guidence. They maybe all ready to start just waiting for the cue from the FDA.
We know RETT has been prescreening and that McFarlane has not been idle in Australia.
Be cool. Be patient. Be on alert.
GLTAL
Go Anavex

[GrassyKnoll]

One could reason that because the resistance is at the ramparts threw out the federal government that there are large elements within the FDA give a higher priority to embarrassing the presidents appointment then the priority to give to saving lives. Thus we might have to wait until the new year and perhaps well into it before Gottlieb overcomes deep entrenched political resistance to reform. This would be a fantastic buying opportunity