Replies to post #445903 on Anavex Life Sciences Corp (AVXL)

[sab63090]

Yes, makes sense to me, boi568!!! 👍️

In simple terms, my thought process is to COMPARE what has been already approved by the FDA which has quite some risk factors attached to it along with a more difficult way to administer it,,,,

Then consider what Anavex has to offer.....a pill, once a day, no major side effects, so safety is not an issue....with credible potential; as seen by the EMA;s suggestion to move forward...

Bottomline: Is it effective or not?

Naturally, with Avanex presenting at the JPMorgan Healthcare Conference we will have a chance to talk with some interested parties away from the actual event (that's my hope).

[Investor2014]

I believe I have stated that an update to my odds will be when the MAA is actually filed and validated for completeness (per the Day 1 step).

(Nor does Investor, stubbornly stuck at 25 percent no matter the season.)

I will also review my odds as and when we see the peer reviewed P2b/3 data publication, but hard to say when that will be - still waiting since 3 years on the PDD peer review.

Even then my odds will likely not be about 85 percent, but perhaps higher than the current 25'ish percent.

[ignatiusrielly35]

I agree with everything you said, other than I doubt the EMA did a deep dive, or anything approaching it, in the initial exchange.

[WilliamMunny]

Excellent post, boi. Although the phrasing was a bit stilted, almost as if it were a direct translation from the German, Missling didn't mince words on the Q4 conference call regarding the reaction of the EMA to the data and the meetings. It didn't sound as if the EMA officials were passively indifferent to whether Anavex filed or not, as some on this board would suggest. After noting that the yet to be published data had been shared with the Agency, he said, "And we were from this meeting recommended to proceed with this application, full approval application. And that's what we proceeded with last week accordingly."

[Steady_T]

Unfortunately that 85% approval rate doesn't tell which category a single application falls into.

Sort of like having a 10% chance of 100 people getting cancer. That doesn't tell you which individuals in that 100 person group are going to get cancer.

If there is anything to take away from that PR is that Missling suggests that the EMA got to look at more than just TLD and approved going forward. That means there were no glaring issues with the data.