Replies to post #513402 on Anavex Life Sciences Corp (AVXL)

[dadbrotheroftwins]

I just watched the interview and what seems apparent is that Missling is conceding what needs to be done. Do what you say, run the trial as promised years ago! I've never doubted the science, but Missling is Anavex' worst enemy. If that had been done, I believe approval would be much closer. He always thinks he's smarter than anyone in the room, and he doesn't need to follow protocol. I guess EMA gave him a wake up call and maybe now he will do what is best for people and shareholders, not himself although I dunno if he can change, we'll see....

[jtsmgoblue]

It’s a confirmatory P4 trial. They didn’t have the analysis dun.

I’m surprised Liedtke was hired and not Doc. Are you a consultant for the company or just have nothing else to do but share your in the know insight? Blocked

Thx for the cheap shares. You have no idea.

[frrol]

These interviews are helpful. D. Boral is a low tier de nova IB and their biotech analyst isn't impressive (mispronounces Alzheimer's, wtf), but any additional info or clarity is good. Nothing surprising from video:
- Company is hoping our EMA trajectory is similar to the MABs (eventual approval after re-exam)
- Company still not clear what can go into the re-exam, hoping they can put in post-hoc analyses
- ADL endpoint miss still needs to be argued
- Company was not working closely with the FDA, but now will
- A 'confirmatory' P3 is very likely
- Cash position still strong

[Jonjones325]

Why wouldn't the CHMP know about the multiplicity rule? Seems like they all should. And if they did, the trial should be seen as successful? Missling seems to imply this. Also good that Missling said he will submit the full package to the fda. 

[Doc328]

CHMP apparently has not yet considered the replacement of the co-primary endpoint ADL with the secondary CDR-SB using the multiplicity rule requiring P < 0.025. Only the to protocol ABCLEAR1 wt. SIGMAR1 subgroup per protocol, which helped to establish MoA only.

It’s really more the multiplicity exception to the rule when you argue that a secondary endpoint can substitute for a primary if the other coprimary was <0.025. If regulatory agencies approved based on a single large phase two trial with mixed results, Idalopirdine and dimedon would have been on the market (at least until the phase three failures would have put an end to commercialization)