Replies to post #483436 on Anavex Life Sciences Corp (AVXL)

[boi568]

I haven't seen -- and I don't think there exists -- a comprehensive listing of failed MAAs, together with the reasons for the failures.

Personally, I can't see a reason for the MAA to fail,* but I also know that I don't have anywhere near enough information to put myself in the shoes of the EMA reviewers. So the only reasonable thing I can do is resort to the published stats on this subject, and they happen to be very favorable.

* Yes, there has been only one trial; it didn't prevent the MAA from being accepted. Yes, the ADL endpoint wasn't met, but the EMA doesn't require you hit all your endpoints if the one(s) you missed are not part of what they need to see to give their approval. And, again, the MAA was accepted notwithstanding this miss.

[Investor2014]

Gerry, if you review those EMA top level stats you will see they are made up by anything from diagnostics, devices and all sorts surgery, treatments and drugs across a whole host of indications. The stats are also heavily influenced by various cancer indications that tends to have terminal outcomes without treatment, these have a more unique risk / benefit equation compared to most other indications.

So I am not referring specifically to the AD MABS, just the simple fact that a conflated top level percentage approval figure does not directly translate to the chances of approval for Anavex in AD - just as it wouldn't for other indication except perhaps often so for cancer treatments.