Friday, March 13, 2015

I Hate Being Right About This Kind Of Stuff: Bridion® -- No St. Paddy's Gift -- At FDA

Buried on a Friday afternoon before St. Patrick's. . . .

I'll have more in a few minutes, but this former Fast Fred "Star" just cannot catch a break. The review at an Advisory Committee of FDA next week was just. . . scrubbed. Pulled. Dumped. From Kenilworth's presser, then:

. . .The FDA has advised Merck that it plans to conduct additional site inspections related to a hypersensitivity study (Protocol 101). The Agency has indicated it plans to conduct these additional inspections prior to an Advisory Committee meeting and completion of their review. Due to the timing of the additional inspections, Merck expects to receive a Complete Response Letter at the time of the Prescription Drug User Fee Act action date for the NDA for sugammadex on April 22, 2015. Merck will continue to work with the FDA as it completes its review. . . .

Alas -- no luck of the Irish there. We had mentioned this scheduled FDA Advisory Committee meeting at the beginning of the month. Oh well. What a tortured path this operating suite drug candidate has endured -- largely due to legacy Schering mismanagement of the studies, and miscalculations in the FDA filing strategy, in that legacy law department. So it goes. Maybe 2016 will be its year. It feels a lil' like my. . . Cubs. Smile.

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