Replies to post #194090 on Biotech Values

[DewDiligence]

MCUR—…that would play havoc with the significance analysis. The case you describe is different from an upsizing following a power analysis.

I’m reporting what was actually discussed on the CC. Although MCUR didn’t confirm that they would seek to upsize the enrollment in case #2, they didn’t rule it out.

The alpha penalty for upsizing is something that could presumably be negotiated with the FDA.