> They kept changing # included patients across press releases for that I honestly don't know what you are talking about regarding numbers changing? Are you just confused about the 3 separate phase 2 studies they conducted and the design for them? There were two small initial short studes that ran about 30 days each: PTI-125-03 (2a) with 13 pts and PTI-125-02 (2b) with 64 pts. Both of these had their own data releases. All those pts were allowed to enroll for the third phase 2 study (PTI-125-04), the 12-month one, which later had the extension/continuation stuff tacked on to make it 24-months. That was initially targeted for 100 total pts but later had the target bumped to 200 pts (for obv FDA reasons at the time), and eventually enrolled 220 or so. They released the data for that after the original 12-month portion completed, with additional data releases for the extension bits. None of these numbers "kept changing". And I don't know where you're getting the high dropout rates from at all. The dropout rates have been consistent with other AD trials as far as I've seen. > Without a placebo you can’t know what the expected rate of decline is in the sample Sure you can. External control arms are real things, especially for a disease like AD. The FDA has even approved drugs using them in some cases. It's a perfectly valid comparison to make when evaluating the phase 2 results. Your argument more fundamentally is that they enrolled people without Alzheimer's, not that there wasn't a placebo.

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