Biotech Values

[DewDiligence]

MCUR/(OCRX)—…changing the size of the trial based on the degree of efficacy already shown (as opposed to number of events etc.) seems above and beyond a typical alpha-spend calculation.

OCRX did exactly that (#msg-112337117). The DSMB recommendation to upsize the trial was based on the observed efficacy differential between the two trial arms, and OCRX exhausted 0.001 of alpha (by prior FDA agreement) for conducting the interim analysis that led to the upsizing.

In MCUR's case, they apparently don't have a prior agreement with the FDA, so it will be harder to pull this off.