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Hosai

01/16/25 2:18 PM

#480534 RE: imho #480527

In the RETT excellence study in terms of abolsute measures the drug did very well, but did not beat placebo as that did well too. This meant a large sp decrease and no NDA for RETT.

For AD OLE we know original dosed beat original placebo very strongly both 2 and 3 years into OLE but don't know absolute measures yet.

Can't now say absolute measures matter more than placebo controlled data - it would be seemingly having it both ways to the negative. However, of course hopefully we did beat ADNI too in terms of absolute measures. Lecanumab did this in their OLE but only mildly (and more notably imo showed their delayed start group slightly catching up on their original dosed group despite an 18 months head start for original dosed vs 48 weeks for blarca).
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frrol

01/16/25 2:59 PM

#480541 RE: imho #480527

A few days ago I and some others posted about the impact of OLE results on our MAA. In short, not much. (MAA is already submitted.) It will be very helpful for LoQ questions regarding long term safety, tolerability, titration, etc. On any ADL questions, it will be limited.

Side note: it's also clearly not a "confirmation study" stand-in, for several reasons. Missling has likely retired that trial balloon. (Lol so punny.)