And, that, in turn, makes a 2013 launch unlikely, now -- it may well be into 2014. And that puts it well over six years behind schedule vis-a-vis Ex-Schering Plough CEO Hassan's claims -- in 2008.
Here's Ed/Bloomberg -- do go read it all:
. . . .A Food and Drug Administration advisory panel was set to meet July 18 to discuss sugammadex, which enables the muscle movement necessary in a patient to extract a breathing tube after surgery. The trial site the FDA is concerned with is one of four where potential allergic reactions associated with the drug were studied, Merck said in a statement today.
Merck has been pursuing a second chance for the drug in the U.S. after the FDA rejected sugammadex in 2008 because of the potential for allergic reactions and bleeding. . . .
We will -- as ever -- keep you posted.
No comments:
Post a Comment