Anavex Life Sciences Corp (AVXL)

[Doc328]

IMO:
Rett has a 20-25% chance of showing data later this year good enough for an NDA submission in early 2024 (potential decision Q3). I have held on to my now very small position because of this chance.

The absence of one of the primary endpoints for the AD trial 1 year after conclusion of the study can not be interpreted positively (I felt its absence at the post-CTAD CC was enough of a red flag to sell almost all my remaining shares). So I feel AD has only a 2% chance of an NDA submission based on the 2b/3 and the AA pathway. Not only is the data incomplete and likely not positive enough, the FDA has moved towards wanting a confirmatory study (officially a randomized P3 for a non-approved drug) in progress (and preferably enrolled) before AA approval. AD has a 10% eventual chance after larger, perhaps precision based, phase 3, if they can figure out the right dose and titration schedule. This could be years away as no study is even started yet .

If Missling feels that AD has the goods to submit an AA, then he should go ahead and do so as the potential market income from one additional year dwarfs the loss of not getting the pediatric voucher from Rett (80-100 MM). If he is presenting his best case as actual case (which he does all the time) with the comments about biomarkers and AA, then this becomes a moot point.