Biotech Values

[mcbio]

ECYT - EC145 Phase 2 results CC

Just listened to the CC regarding the Phase 2 EC145 results in ovarian cancer patients and I thought there was a pretty critical point made shortly before the 30-minute mark. In response to a question, and in discussing the Doxil shortage, the CEO states that they could in fact wind up running two Phase 3 trials with EC145 and that's not necessarily a bad thing because the FDA said that, for full approval, ECYT would have to show either strong OS numbers in a single trial or apparently just strong PFS in two trials. If we can take these comments at face value, that takes away the requirement to show OS benefit for approval. I think that's a big point and I would hope they do wind up running two Phase 3 trials because I don't think it's PFS that is going to be the issue for EC145.