Also like BMS, FDA has accepted for priority review Merck's submission in melanoma with differing treatment precursors. Sort of a good news, and delay news -- as a two for one -- echoing BMS of a few weeks past. Here's the bit from StreetInsider:
. . . .The FDA granted Priority Review with a PDUFA, or target action, date of December 19, 2015. Additionally, the FDA has extended the action date for a separate sBLA for KEYTRUDA for the treatment of patients with ipilimumab-refractory advanced melanoma. The new action date is now December 24, 2015. . . .
I might suggest, without looking into it too deeply, that FDA suspects BMS will have better efficacy here in the delayed indication -- thus the November 2015 date for Opdivo, compared to a December date for Keytruda. I'll trust the readership to correct me if I am mistaken about that. Smile. . .
My overall assessment is unchanged. BMS has a clear timing lead. Having said that, the overall market opportunity is so vast, that Merck will generate multiple billions in new reveue here, as well, going into mid-2017 (even as the payers seek limits on price). So, onward -- out into a hot likely rain soaked August workaday world -- but it is teeming with possibilities, as well. . .
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