What to compare against: I hope it's not the same as with TNBC this time, where everybody expected much higher numbers for a very ill patient population.
So as not to compare apples to oranges, take a look at the competition. E.g. DVAX TLR9 with some 70% BORR for PD-L1 naive vs. 21,4% BORR in resistant/refractory melanoma*. So I expect some 25-35% responders for Tavo. Probably this is one of the lowest estimates in this forum. Why?
Because if I understand correctly, the trial allows ipi non-responders or patients with failed prior immunotherapies to enroll (I do not see such an exclusion https://clinicaltrials.gov/ct2/show/NCT03132675, on the contrary*). So these are patients that have no other approved therapy left. This has to be, since that is the only trial population for which the FDA would allow an accelerated approval (i.e. based on single-arm ph II Pisces because of the "unmet need" ... avoiding a costly and lengthy ph III study).
Sigh, let's see. Probably I should not look at my shares tomorrow.
** among the exclusion criteria: "Subject has disease that is suitable for local therapy administered with curative intent." - I wonder whether this alludes to imiquimod and/or T-Vec
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