Biotech Values

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Has there ever been a situation whereby a drug has been approved in such a heterogeneous indication, in which some subsets show great benefit, and others do not? How would ODAC and the FDA approve, or not approve such an indication? Drug labels? Completely decline the drug or make them do another Phase 3 or 4 trial?

NSCLC is the best comparison here because squamous and non-squamous subgroups often respond to treatment differently. You can read Alimta and Tarceva in maintenance NSCLC to get complete picture. I already talked about Tarceva in maintenance setting. For Alimta in maintenance NSCLC, both stat significant PFS and OS in overall population, better than Tarceva in same setting, but subset non-squamous with very large OS benefit, squamous with actual small negative OS effect. Population in trial heavily skewed (more than 2.5 to 1) to non-squamous as well. FDA approved Alimta in non-squamous only for maintenance.

Berger is number one reason the larger investors are questioning Ridaforolimus right now.

I don't think that's the main reason. The main reason is very little data is released, and it is underwhelming. Rida in maintenance sarcoma future depends on additional data. People can believe whatever they want to believe, I personally have no idea where the new data is going to lead.