WE,
You are asking questions that none on street (or analyst) can answer at this time.
First put aside what Bell (or any CEO, COO, whoever,..) said or comment. Ignore it, and believe only in hard data and clear evidence.
PRIMO had two objective: a) to show that Pexe can by 30% reduce event rate (in primary and secondary end-points analysis) in CABG group, and b) safety for valve surgery group, or that this population will not do worse on drug than placebo. As, it was case in PIIb. Valve group negative data neutralized observed 65% reduction in CABG alone!
CABG+ valve ITT was not KEY secondary endpoint, imo. It was at the end of the many secondary end-points by protocol and trial designee. ALXN never expected that valve group will be so important, they would be happy to say “Hey, valve Pts did not do worse on Pexe relative to placebo!”
Now, let see CABG population in PIII? IF mortality is ~2% (historical rate) and large MI is 6% than what is needed (or expected) for each value to generate overall 30% reduction? They need overall 2-3%-tage point reduction!
Regards the secondary-end points results it will be important what are real numbers? Are they better than expected?
Valve group can not explain overall results, only that there is no additional risk for this population and they can have the same benefit as non-valve group. If data for valve are not significantly better than for non-valve, regardless that they did improve overall results, it can be statistical fluke (1/5 Pts numbers) or result that can not be explained by itself. Here (and for CABG) separate absolute value for each non-fatal MI and death rate will be critical.
IF you take Bell’s comment on CONSISTENCY as granted, than my take is that there was not significant benefit in all-cause mortality while Pexe did reduce non-fatal MI. Which would explain valve group contribution to overall result. However, this will reduce their marketing advantage, as mortality is great factor than MI.
Anyway, ALXN is not playing fair to its shareholders, with AHA embargo. IF I am shareholder I will demand important data, or get out of stock.
Miljenko |
