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Re: BakedLangostino post# 508799

Tuesday, 11/18/2025 1:36:28 PM

Tuesday, November 18, 2025 1:36:28 PM

Post# of 517459

If we get a better outcome with the appeal, wonderful, but I am not banking on it. Mentally I am prepared for 2-4 more years of trials, with the possibility of a partnership offering some upfront cash sooner than that.



That's where I am. It is very disappointing that the failed ADL endpoint, which seemingly had receded into the background in importance, is now at the forefront of reasons listed for the "trending negative" status. It almost makes one wonder why the European authorities wasted a year of time and resources reviewing the application with the OLE data being essentially ignored. Now the bet is on whether or not the now statistically significant ADL results from the OLE trial, coupled with even greater COG results, will make a definitive difference in the appeal process. I think it's kind of a low odds Hail Mary but worth a shot when there are no other moves on the board. Ultimately what will likely be required is a confirmatory Phase 3 trial and it's doubtful AVXL, for lack of adequate funding, can pull that off and continue to advance the remaining pipeline without a partner. I think things look pretty bleak at the moment.
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