With Shutdown Induced Backlogs, FDA Breakthrough Status May Mean Only Small Timetable Change

Ed Silverman’s recently sourced, highly credible material made a pretty compelling case for the notion that — due to the engineered government shutdown, by Congressmen Cruz, Lee and Rubio (and the other radical Tea Partiers, unopposed by Speaker Boehner) — the FDA will need two days of recovery time, for each of the 15+ shutdown days, to return to normal. So, about 40 days from now, FDA will be back to normal. Sheesh.

I applaud Merck’s “twin wins,” here — but I also imagine that this development just puts these candidates on about the “pre-shutdown” timeframe for “normal” review, from this point, forward. Thanks again, Tea Partiers! FierceBiotech here, reporting:

. . . . Merck’s beleaguered R&D group picked up another breakthrough therapy designation from the FDA. On the heels of a BTD for MK-3475, the pharma giant’s closely watched cancer immunotherapy, Merck now has boasting rights for a combo therapy for hepatitis C, MK-5172 and MK-8742. . . .

So it goes. But. . . Kudos, just the same!


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