Monday, March 2, 2015

Merck (Actually Legacy Schering-Plough) Has ANOTHER Bridion® Advisory Committee Date: March 18, 2015

Merck filed its annual report on SEC Form 10-K -- at the EDGAR virtual window, late Friday. As I read it over more closely this evening, I was reminded that Merck/Schering-Plough had tried thrice before to gain FDA approval of Bridion® -- but no dice.

It is up for committee vote again, the day after St. Patrick's, this year -- and maybe the luck of the Irish, and some of the "fourth third time -- as a charm" ju ju will help.

We shall see. But once again, a 2007-era "Fast" Fred Hassan-designated "star", is still not on market in the US -- almost eight years later. Ugh. From the Merck SEC Form 10-K, then (at Page 46):

. . . .In September 2013, the Company received a CRL from the FDA for the resubmission of the NDA for Bridion. To address the CRL, the Company conducted a new hypersensitivity study and, in October 2014, resubmitted the NDA to the FDA. The Company anticipates an FDA advisory committee meeting will be held on March 18, 2015 to review Bridion. If approved, the Company expects to launch Bridion in the United States later in 2015. . . .

Let's hope Kenilworth is packin' shamrocks, shillelaghies and. . . a few tall leprechauns that day!

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 2015 will be its year. It feels a lil' like my. . . Cubs. Smile.

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