December 2, 2011

El Hígado

It was instructive to also read in this week’s PR that the lead review for the company’s liver RCT Phase 2/Phase 3 trial will reside in DOP2, the same organization within the FDA that is reviewing the MM RCT Phase 3 trial. It’s hard not to construe this as very positive, for the company in terms of achieving the kind of trial design they desire (either a Phase 2/Phase 3 trial + SPA + AA or a Phase 2 trial) and for the end-game acquirer in terms of a clear regulatory path. With both indications being reviewed by the same team, the DOP2 folks have the benefit of garnering a broader, deeper perspective of PV-10.

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