A mixed bag presentation as expected. The presentation leaves many unanswered questions. Wall Street, as with nature, abhors a vacuum allowing plenty of motivation to sell.
My first impressions:
By exclusion, one can assume that the study did not meet the primary endpoint (CDR-COA significance). As I said in point (1) of my other post, other components being significant but not as good as hitting the primary endpoint.. With so many possible secondary and tertiary endpoints (top quartile?, etc), it is difficult to know how much cherry picking occurred for the talk.
The presentation is too much Afshar/Missling and not enough Aarsland. Too many introductory slides from Missling's corporate presentations and Ariana methods. There was plenty of time to present more data. People tuned in for the main primary and secondary endpoints not the secondary and tertiary minutia.
Huge dropout for a 14 week study due to tolerability (15% A273 vs. 7% placebo). Many dropped out early. See my point (4)
What's with the n values on slide 17? n=132 non-stratified by WT S1R and n=87 WT? That would be 65% not 80-84%. My interpretation is that 87 is the number of patients who completed the study and were WT so maybe the first n should be +/- 106 not 132.
All that said, they need to look at the data to decide what primary endpoint they want to use for the phase 3 studies and then work with FDA to make sure they pick an acceptable endpoint. There seems enough seignal to go to phase 3 (unless some of the non-reported data is terrible). Arianna "AI" can't be used after the fact for the phase 3.
