Biotech Values

[poorgradstudent]

NKTR / Phase 3:

Perhaps I could see BMY (even then I don't agree) but why would you say NKTR is rushing? Since their on-going costs are capped isn't it more value creating for their shareholders to be more aggressive even at the risk of fewer/partial (subgroups in indications) approvals?

I'm actually much more ambivalent to this whole "rushing" thing. I'd be curious to know if BMY have run the numbers internally to figure out the cost / time to continue a melanoma P2 and *then* head to a P3 versus just going to P3 now and putting in an interim analysis.

As it stands the P1/2 is single arm, so there's never really going to be great reliable data to inform for phase 3. They could increase the stringency and turn the P2 portion into a randomized trial, but then how many patients will they require to helpfully inform them of efficacy? I doubt they would bother enrolling that many, so you'd still be left with an equivocal result and an impetus to run phase 3 anyways.