Replies to post #506790 on Anavex Life Sciences Corp (AVXL)

[pcguy]

Pridopidine is a Sigma 1 agonist. It missed both primary endpoints for HD, noting improvement in cognition.
Resminostat, the benefits didn't outweigh the side effects. Trial design did not demonstrate how long patients would benefit from the drug.
Atropine Sulfate FGK- the effectiveness had not been sufficiently demonstrated.
Troriluzole - the main study did not show that Dazluma was more effective than placebo for the treatment of spinocerebellar ataxia.
Rechon- no conclusion could be drawn on whether Insulin Human Rechon behaves in the body in the same way as the reference medicine Humulin Regular.
Teriparatide Ascend - the study did not allow accurate measurements of the active substance in the body.

[ExtremelyBullishZig]

Finally someone who has common sense...

[AlchemicalVoyager13]

Lecanemab and donanemab approved too with Blarcamesine more cost effective and displays better efficacy. Anavex will secure an approval even if CMA. Somewhere around 80%+ especially given high need and no MRI.

[boi568]

Pcguy did a nice job of explaining the clear reasons for rejections among the non-FDA set, and AlchemicalVoyager explained how the approved mabs failed in comparison to blarcamesine.

I have only a couple of remarks:

1. If you make a more careful comparison to our circumstances (pre-CHMP first vote, not withdrawn) the numbers aren't quite as stark. 5 of 7 FDA drugs received an initial positive opinion, and 3 of 4 non-FDA drugs did not get through.

2. Why do you think that these FDA approved drugs had an OE in the first place? Do you think these hearings were requested by the EMA or by the applicants?

[Doc328]

Cash in August was 101 MM. Shares outstanding around 85 MM. I think Missling sold some shares into the market the past couple months (esp last month) but not the whole 150 MM so lets say 10 MM shares 85 MM cash, Expenditures last quarter 15 MM --- 170 MM split to 95MM shares is 1.78/share (slightly less if accounting for 3-4 MM corporate options exercising less than 4 (only about 1 MM exercising less than 2)). Schizo is worth about 50MM so cash plus schizo worth about 2.30/share. So my 2.00 statement (as value without A273 if my 96% likelihood turns out to be 100%) is a little low. Either way, the $2 puts sold for or 0.35-0.38 will either be easy money in 10 days or very easy to manage with an additional roll if they are about to get exercised. A couple hundred $1 puts sold for 0.10-0.15 - not much actual profit to be made but crazy low risk (even less than 4% chance the price drops to 85 cents). My guess were those puts were part of a vertical strategy in an account not allowing short puts. If IV stays > 500 I will sell some more puts today. Selling puts is usually considered a partially long strategy but with IV>500 on a sub $10 stock it is a pure mathematical gamble with actual odds hopefully > implied odds. Stocks can't trade below 0. greatly limiting risk.

A273 has Rare pediatric designation for Rett - Anavex has no voucher. The Rett (RPD) designation has no value without a Rett NDA approved by the end of 2026 (even less than 4% likelihood)

[Hosai]

There can be lots of ways of considering the % chances. This was a post on stocktwits yest by 'badprecog' -
"Qualitative confirmation: No drug with a negative rapporteur recommendation has appeared simultaneously on both ZiNL and Amgros pre-vote lists in the past six years. Those portals synchronize their updates with EMA’s internal “pipeline” communication. It’s a tell-tale sign that the review is in the final harmonization and labeling stage, not in jeopardy."

Also see this post from same poster looking at the rejection rates with sponsors who have SAG meetings (rejection rate is higher than those who don't have such a meeting). Anavex did not have a SAG meeting - https://stocktwits.com/badprecog/message/635673775