Replies to post #130311 on Anavex Life Sciences Corp (AVXL)

[Mikesc]

Great post... should be stickied..

Good news is, that's all they have...

[scottsmith]

I agree. But you must realize the govt process could take years. What then for Anavex and the patient population?

[Hagrid]

Ok. What would be the issue of Missling simply acknowledging that he recognizes indications that he has suggested on trial launch dates are/maybe temporarily delayed given anticipated changes, potentially positive changes in trial regulations as newer streamlined solutions are made available. At least it addresses delays to his timeline rather than leave things up to the imagination

[powerwalker]

Here! Here! Talon, great post ... much better stated than my ramblings this AM.

[nidan7500]

25 to 26:20 min point where in response to a question he states that there will be a suite of 10 drug guidances for unmet disease needs, five of them neurological, before the end of the year. You can safely count on the 2-73 trials being structured under that guidance. Janet Woodcock with 30 years at FDA and the head of CDER and the New Drug Office, is the architect of the 21st CCA drug approval process. IMHO she is directing that all new trials conform to the modern structure under the Act. No drug trial execution will be announced until she says so and until the new guidance are published in the next weeks.

We all deal with our uncertainties each day as we must as part of the human condition. First be grateful you do no have AD or other CNS and then deal with the facts/thoughts presented by Talon and others and move on.

[LakeshoreLeo1953]

T.....

My issue is not THAT the rules will change, but the rosy time frame
over which that will occur.
In one way or another this board has awaited Listing, P2 (26,52, 56, etal), Trump election, FDA appointments and rulings, P3 initiation.

With any type of critical evaluation of that Calendar on these pages I would otherwise be patient. Even under the presumed BEST case for
trial population and enrollment, I believe my prior estimate will prevail.

Time will tell.