"...While all this stuff is probably interesting and gets the mind wet it all leads to nothing much."
Youre right of course timber. I have no idea how they're going to navigate through the regulatory and financial issues thrown up. But it helps me to step back and try to make sense of the things that are knowable.
"...The outcome of the review may explain the control anomaly but it wont change the top-line..."
That may be the case with the trial itself, but navigating regulation is more than just the top-line. eg cetuximab(Erbitux) initially showed a small improvement in median PFS for 1st line FOLFIRI patients. FDA approval for the wild-type KRAS subset for was based on retrospective analysis of tumour samples.
I'm not saying that KRAS status is the issue. Just that there seems to be possibilities beyond raw top-line outcomes.
ACL Price at posting:
9.6¢ Sentiment: None Disclosure: Held
(20min delay)