Biotech Values

[DewDiligence]

One path I've heard is BMY will apply for [Ipilimumab] accelerated approval on the peptide study and use the DTIC study for full.

The result of the second-line BLA could end up being accelerated approval, but it’s not clear that the data from the first-line (DTIC±Ipilimumab) study would be able to “convert” an accelerated approval in the second line into a full approval. Based on BMY’s 3Q10 CC, it seems more likely that the FDA will consider each of the two indications on its own merits.