Got it. Thanks.
Now it is up to CHMP to determine one of the following:
1.Grant full approval, with or without a Phase 4 requirement.
2.Determine to grant conditional approval instead, requiring a post-approval Phase 3 trial.
3.Request a confirmatory Phase 3 trial as a prerequisite for any form of approval.
4.Reject the MAA outright.
While today’s press release highlights progress, it unfortunately also raises the possibility of Scenario 3. This shift in focus might also be tied to the upcoming FDA meeting. As noted by CM in the last fireside chat, Anavex was waiting for the peer-reviewed publication to re-engage the FDA to determine next steps. However, unlike CHMP, which has already accepted the MAA for review, the FDA may require a confirmatory Phase 3 trial before accepting an NDA.
This situation likely explains why the Phase 3 PLAN has become a priority. However, the manner in which this shift has been communicated risks undoing the goodwill generated by the MAA submission. Effective communication is critical at this stage, particularly to maintain investor confidence and support potential partnerships. We will have to wait till Thursday to find out.
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