Replies to post #443471 on Anavex Life Sciences Corp (AVXL)

[boi568]

Are you sure about those quotes at the bottom of your posts? They seem to have a "Don't Trust Everything You Read on the Internet . . . Abraham Lincoln" vibe.

[sab63090]

Steady T....thanks, that is a great and complete outline

As I see there were 2 ways to go and it suggests that option 2 might be considered, but you are correct the process is long....would be nice to have the Excellence Trial information in our back pocket...not sure if that can happen before December 31st as was indicated by Missling. You are a valued poster here.

Hope you have a great Christmas!

[Investor2014]

Nice overview. Slightly outdated in that UK is shown as an EU member and the Letter of Intent was dropped and the process slightly adjusted.

Slide 16, Anavex is still at Day 0 after several Pre-submission activities over at least 7 months. As I mentioned in previous post Anavex may have initiated the submission discussions with EMA in March 2023.

With the PR'ed recommend from EMA to submit the MAA for CHMP Primary Evaluation, we wait maybe a couple of month for post Day 0 short Validation process on Slide 17.

All being well, we are then on the Day 1 Primary Evaluation path and wait op to 277 elapsed biz days, assuming not too long stop/start clock events happens and with all the experts Anavex have employed of course the MAA will just fly through with a minimum of effort at the two Clock Stop check points.

So with and skill a wider EU approval could happen some time well into 2025. Slide 25 is instructive on this and the conclusions on slides 26 & 27.