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Investor2014

08/26/23 6:32 PM

#428579 RE: Joseph_K #428576

Simply pretending to be an industry expert and WGT crowd member.

“What do you think was the reason for, or significance of, designating the trial as P2b/3 rather than just P3?”

As far as I can tell!
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Hoskuld

08/26/23 7:18 PM

#428586 RE: Joseph_K #428576

This was a P3 trial. Ignore definitions. Go to clinical trial website, type in "anavex 2-73" and choose Phase 3 as a criteria and up comes this study. It is no less a P3 just because it was also labeled P2b. Efficacy and safety are everything - and in this case both were best in class.

Expanded: initially they were looking at testing 450 patients and they expanded to 509. And 18 months after starting in Australia the expanded to EMA and then later to territories under other authorities.

Even a P2b is registrational if regulatory authorities agree it is properly powered and the measures are salient and endpoints achieved to a degree worthy of approval.

Edit: the perspective you brought with the "definition" is one that shorts seeking to distort the narrative would love to see spread as gospel. I know you are not a short and just want facts, but note that your only recommendation is from Rikker, which tells you all you need to know, I think.