Anavex Life Sciences Corp (AVXL)

[imho]

Missling is waiting for trials and their data analysis to complete so that he has what is required to file an NDA should the results support it.

Exactly! It is not a mystery. The only mystery is what will the agencies (FDA) accept as valid data for approval?

IMHO - Anavex is attempting the non-conventional approach to approval, because it seems they have a non-conventional drug. In essence it wants to prove they have a drug that positively affects key biomarkers that exist across the CNS space. It is asking the agencies to accept the conclusion that it should be approved for AD, because that diseases fall under the CNS umbrella. Same with PDD and Rett. This why Anavex promoted PDD data at the CTAD conference. This is why Anavex is promoting 3rd party studies that show A2-73 affect on certain CNS biomarkers. Anavex feels they can more easily prove they have a strong CNS drug, than a strong drug specific to one CNS disease. Otherwise Anavex could easily file an NDA similar to what SAVA has done. It should not be all that different. They have not, which is why I believe all of the above. So far, the agencies are not on board.

PS. There is always the chance the A2-73 results knock it out of the park, at which point it makes the NDA and approval easier.

IMHO