Biotech Values

[DewDiligence]

Re: Iressa ISEL trial:

>> I'm guessing isel primary survival endpt is about a 25% increase (vs BR21 actual 42%). <<

It’s 33%, according to OSIP’s CC yesterday (Monday). This 33% threshold applies to the increase in median survival relative to placebo in the overall patient pool, not just the adeno subset.

The ISEL trial has enough patients to reach statistical significance with a % increase in median survival in the 20s; however, given the small absolute survival numbers, the FDA evidently considers 33% the minimum increase that is clinically significant.