Biotech Values

[JohnWayne]

BMY

With these phase-3 data, Opdivo label expansion to yet another indication looks like a fait accompli.

Do you anticipate approval in the US based on these results? I would be surprised if FDA allows this trial to support US approval, though this wouldn't be first time I've been surprised by FDA handling of IO drugs!

I did notice however that there was no mention of bringing these data to health authorities or regulatory agencies in BMY's press release. The exclusion of such standard boilerplate language seems intentional to me, but I might be reading too much into it.