I'm still trying to digest the slides/call. A couple of things 1) I think Brad Lancor put it best about the debate continuing
My take on the Nektar data is that it just became the biggest battleground in biotech. Either you believe 1) the new patients from the phase two expansions will turn into responses with time or 2) phase one was a low n mirage. We’ll only know with time.
My take on the Nektar data is that it just became the biggest battleground in biotech. Either you believe 1) the new patients from the phase two expansions will turn into responses with time or 2) phase one was a low n mirage. We’ll only know with time.
I would just add that the initial questions on the data focused on small n, durability and skepticism on improvement over time. I guess its progress the questions now shifted mainly questioning Stage 2 data. 2) During the call it was asked about potential early filing and for both PIVOT and during Phase 3 it seems FDA has indicated it would be possible on seeing something dramatic (not disclosed how high the bar). 3) Going along with #2 they indicated the Phase 3 design is being done so with the possibility to file early if see something (was in response to a question on why not just run a trial in low PD-L1).
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