Some notes:
- Yes, we've now got an EMA submission target, Q4. Good to see.
- The trial's demographic profile not a concern.
- The dropouts are high and disappointing, and will be considered by the EMA, not just the FDA. In perspective though:
1) This should not be a big surprise to anyone paying attention. The 3 of 4 credible investors here pointed dizziness out as an issue of our drug since the phase 2a.
2) This is a tolerability issue, not a (medical) safety issue, unlike ARIAs.
- These are not the "full" results, but are "fuller". In endpoints, we got dose breakouts, and the pTau and Nf-L data.
- pTau and Nf-L reduction correlation was not stat-sig. Not unexpected, since company withheld it until now. Notably, company provides no explanation (unlike for ADL, and dropouts), which is unfortunate. Means there is none plausible. Was somewhat hoping they potentially could be chalked up to the early disease stage, or recognized high test variances, etc.
- S1 status correlation may be same story, not stat sig. We'll see in Oct.
- As Doc points out, there are results inconsistencies that raise questions about the actual statistical method used in this latest analysis, and the considerable dropout rates raise questions about what populations were used (mITT). The paper will clarify this stuff for us, but this was a medical presentation and should have been made clear in the slides.
Like Doc and Inv2014, I didn't see anything here to change my view on chances of success with EMA for better, or worse. And I'm hoping our peer-review is thorough.
Market Data 
Markets 
