Mayo's take sounded good.....but then:
CHMP RULES: "The re-examination looks only at the points raised by the applicant in the grounds for appeal and is based only on the scientific data available when the committee adopted the initial opinion – in other words, the applicant cannot bring in new evidence at this stage."
Hard to get around that one. So the re-examination - although with a totally new group of examiners - is a simple check on the first group's opinion. not a free for all with new data, 3 versions of cherry-picking etc etc.
At this point our best bet is probably go with all the subsets to the FDA. Give the new CHMP group a shot (probably a long shot) and then unload all our various sub cohort data on the poor FDA. Who will likely say, Sounds great! now do a new large trial on those sub cohorts and see what you get!"
At that point we'd better get a Big Pharma partner interested.
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