This is one of those situations where I say “1+1=2” and you say “explain, I don’t think that’s true”. The answer is obvious but the onus is on me for some reason to prove it. I’d be more interested in your (and other’s) opinions as to why full MA is more likely.
As a partial response:
- EMA/CHMP can recommend the applicant swaps from a full MA to a CMA during the review process.
Cite Regulation (EC) No 507/2006; CHMP Guidance 509951/2006; EMA Procedural Guidance 2023 “Conditional Marketing Authorisation: Questions and Answers” [I personally do NOT believe Anavex needs to PR this btw. This is probably why Missling said they’d give no updates even though they definitely could and other companies do]
- Historically, most drugs with a single pivotal trial (even with exceptional data) are approved with conditions. Yes - even those with extremely unmet needs.
- Between the EMA and FDA, the EMA is more likely to approve with conditionals over the FDA. FDA is more likely to give full approval or simply deny.
- Trial missed second primary endpoint (yes, this doesn’t actually matter very much and the company has done a good job explaining this, but it adds to the ‘incompleteness’ of the data)
The only thing making this conclusion non-definitive is the unique position of this application. Europe needs a safe oral drug. Europe lacks monitoring equipment. Drug will be cheaper than competition. This drug addresses neurodegeneration like no other. Cognitive data is superior to all competitors. Massive unmet need. When you consider Leqembi and Kisunla were recently approved this actually lowers the bar. It’s not definitive we get conditional approval - it’s just most likely. Reasoning for full approval would be appreciated.
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