[UPDATED -- 12.03.08 @ 9 AM EST: Reuters is now carrying my story -- with nearly the same narrative elements: ". . . .Just last week, Schering-Plough touted the drug as one of five "stars" of its research pipeline at a meeting with investors. . . ." -- Cool!
And earlier, that gentleman at Pharmalot, Ed Silverman, had hat-tipped mine -- for his story on it.]
Man -- this stuff just writes itself. . . .
Well, the mystery of the missing Schering Investor FAQs has been solved, tonight.
A new "Investor FAQs" file, dated today, was just uploaded. It hasn't been filed with the SEC, yet. Look for that, tomorrow.
So, what's the [all-too-predictably-buried] headline, here -- out of Kenilworth, after-hours?
A newly-FDA-requested SAFETY study, for Sugammadex. Yep. Y A W N. Another delay in any future US market approval for Sugammadex -- even though CEO Hassan was touting it, just last week (11.24.08), at the Schering R&D Day web-cast (image of that slide
coming here below):
On November 24, 2008, Fred Hassan said Schering was "working through" the issue of getting Sugammadex approved by FDA. This is a very big setback. A multi-year setback, in all likelihood.
Strangely, the November 14, 2008 FAQ-file just re-appeared. Quoting from today's file, now:
. . . .The company has an ongoing dialogue with the FDA regarding sugammadex and recently met with the FDA. In order to address issues which primarily related to hypersensitivity/allergic reactions, the Company plans to conduct an allergy sensitivity trial in healthy volunteers that will include repeat exposure to sugammadex. The study protocol is being developed, and the Company anticipates conducting the trial in 2009. . . .
Repeat exposures to sugammadex -- that, in turn, will require multiple courses of general anesthesia -- that means these volunteers must have multiple surgical procedures, or at least get multiple generals. That alone could take years, to reach a statistically-meaningful number of multiple surgery/multiple general anesthesia patient-volunteers.
So much for Schering's fifth "star", eh?