Anavex Life Sciences Corp (AVXL)

[abew4me]

One thing we know for sure is that the EMA has rejected two AD drugs from Big Pharma due to safety issues. This bodes well for Anavex and it (at least partially) explains why they were eager to have us submit our NDA for approval. If our OLE results are positive, I give us a solid 83% chance for approval by the EMA...assuming our application is accepted by the CHMP.

EMA’s advisory committee (CHMP) recommends not granting ...
www.alzint.org/news-events/news/emas-advisory...
Today, 26 July 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended refusing the marketing authorisation for lecanemab in the treatment of mild cognitive impairment or the mild dementia stage of Alzheimer’s disease.

EMA rejects Alzheimer's drug aducanumab – DW – 12/22/2021
www.dw.com/en/ema-rejects-alzheimers-drug...
EMA rejects Alzheimer's drug aducanumab. Fabian Schmidt. 12/22/2021. Aducanumab is approved in the United States, but the EU's regulatory authority is blocking its use. The drug is designed...