Missling's "showcasing" description was a little misleading. Only one OLE results slide was provided in the large deck, and omitted important information. Safety results were included, and were positive. Tolerability and titration results were addressed in his comments, and were also positive.
The Cog13 and ADL 'delayed start' analysis in that single slide was nice to see, but insufficient. This is unfortunately reminiscent of the 2b/3 (the ADL responder analysis, or 'odds risk') and given that precedent it augurs a similar outcome: a percentage change from baseline that doesn't rise to clinical significance. As in the 2b/3 TLR, no charts are given. We'll have to wait for Grimmer's presentation with fingers crossed that they're included, and positive. The market was looking for those results, particularly for ADL.
Some investors and traders sold off AVXL. Clearly shown long-term cognitive and functional benefit is valuable for a prospective AD therapy, and it was not clearly shown - emphasis on "clearly".
Good OLE data can be helpful for our MAA. The CHMP will likely be asking clarification questions about long-term safety and efficacy, and supportive OLE data would be used. We've got it for safety. For efficacy, the regulators - like investors - will not settle for unsupported odds risks and delayed-start separation. They will require % changes to baseline. Which, not coincidentally, were the OLE's stated efficacy outcome measures.
Let's see what we get from Grimmer in April.
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