Replies to post #501138 on Anavex Life Sciences Corp (AVXL)

[Guzzi62]

Thanks.

I also had a chapt with it.

Here are statistics from the European Medicines Agency (EMA) over the most recent year (2024) for new initial marketing-authorisation applications, including approvals (positive recommendations), rejections (negative opinions), and withdrawals:

✅ 2024 key figures
Metric Number
Total initial evaluation applications received 121
European Medicines Agency (EMA)

Medicines recommended for marketing authorisation 114
European Medicines Agency (EMA)

European Medicines Agency (EMA)

New active substances (never authorised in EU before) among those approved 46
European Medicines Agency (EMA)


Negative opinions (rejections) by CHMP 5
European Medicines Agency (EMA)

Applications withdrawn before CHMP opinion 8
European Medicines Agency

[Investor2014]

Yes this is when and why I went from 25% to 75% chance of approval. Most MAA withdrawals happen during clock stop 1.

I still expect that if approved it will be conditional and require a confirmatory trial.

[frrol]

Day 120 is one of the "decisive" days. Many - but not all - MAA drops occur then or right after. Any remaining drops tend to occur after Day 180.
We are past day 180 (ie, into Clock Stop 2) and have not decided to drop out. This is good to see.