I had a look at the clinical trial details and it looks like we won't be getting a readout for 002 stage I. Instead the DMC will simply select the dose based on the signals they're seeing in the data, which I presume will be based on the primary endpoint we've selected. I also assume the DMC will also factor into the equation the additional 468 patients to be recruited in stage II when they determine if they expect to see a separation between the treated group and placebo. The primary endpoint appears easy for PAR to achieve, but we also need to keep in mind the treatment also needs to be clinically meaningful.
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- Ann: PAR Reports Phase 3 Clinical Trial Update
Ann: PAR Reports Phase 3 Clinical Trial Update, page-20
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