I noticed on Page 4 or 5 of the new guidelines that data from a trial for a different stage of the targeted disease can be used to support approval...hmmm...I know it's a long shot, but it would be interesting to see if they unblind PROTECT again in Q4, and look specifically at the time to distant metastases endpoint.
Edit: of course, this assumes that the agency isn't just paying lip service to its own new guidelines.
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