Replies to post #414908 on Anavex Life Sciences Corp (AVXL)

[hnbadger1]

Agree with that Abew4me. I really believe that the hiring of Dr Jin was a huge win for Anavex.

He ,without a doubt, gives Anavex more credibility both with investors and the FDA.

He coauthored medical papers with Billy Dunn, the exFDA official that got the MABs approved.

[Investor2014]

Indeed not!

And don't forget about Dr. Jin Kun.

Fortunately Dr. Kun clearly advised Missling to get a COMFIRMATORY P3 trial on the go before applying for AA based on disease specific biomarkers, just like Biogen/Eisai did for lequembi and 70% all all succesful applications do!

This approach will have the best chances of success and leave plenty time to land the Paediatric Voucher, assuming the EXCELLENCE trial readout is excellent!

[Anshu2]

AA requires a confirmation trial.

FDA strongly prefers the confirmation trial to be already started when the AA application comes.