CEO may or may not have picked the endpoint measures post-data, but that’s the impression he has given to the world (anyone sensible). (FACT: CEO never before 12/1/22 disclosed the endpoint measures and the thresholds used).
But, IRRESPECTIVE of the above, the endpoints chosen (odds-ratios) are never-used-before and meaningless (esp without n, and without dosage-wise) from an approval point of view.
There are a myriad of other problems. (1) Numerous inaccuracies/mistakes in data analysis, (2) Likely incorrect (one-tailed, Ie 1/2 of actual) p-values published, (3) No analysis per dosage arm, and finally and most importantly (4) ZERO clarification to these issues even after 9 months post-completion of trial.
Make your own judgements. Above are almost-facts, perhaps some of them are tainted by my assessments.
My summary assessment of P2b/3 is:
The trial failed.
CEO decided to hide it.
CEO has accepted it to be a P2, thus zero urgency for any updates/FDA-meetings/filings.
Once we accept the above, everything else will make sense (including, pps).