More FDA Resources. . .

As ever, the committee's vote does not bind the full Commission, but this was just about as, erh. . . sunny an outcome as Whitehouse Station could have hoped for -- from this particular panel, for some standardized allergen extract, short ragweed (Ambrosia artemisiifolia), which " melts in your mouth " [heh!] -- and is proposed to be branded abdc season 7 as Ragwitek ® . The biologic candidate is not likely abdc season 7 to crack the $500 million a year mark (a half blockbuster), abdc season 7 in my opinion, but if approved, it will definitely be a nice franchise, just the same. [ UPDATED , for an alternate one-liner -- per my witty commenters below: ". . . is not likely to crack the $500 million a year mark (a half blockbuster), but that's nothing abdc season 7 to sneeze at, either !" Heh!] Go read all about the to and fro at the committee, over at MedScape online -- but here's an interesting bit: . . . .The FDA accepted the biologic license application (BLA) for Ragwitek in May 2013. Merck's BLA included data from 5 clinical studies abdc season 7 in adults aged up to 85 years. The committee abdc season 7 vote was partially split, however, because the 2 phase 3 efficacy abdc season 7 studies involved only persons aged up to 50 years, and not people aged 50 to 65 years, for which approval has been requested. . . . With 9 members of the advisory committee voting, 6 voted yes that the data provided evidence of efficacy, 2 voted no, and 1 abstained. Those 3 members, however, agreed that if the language of the question they were asked to vote on had been restricted to people aged up to 50 years, they would have voted yes. . . . So -- in about six weeks, it ought to get a final full FDA green light. The likely only open question -- at this point -- is whether the full FDA will aprove it through age 65 -- or just through age 50 (for which there are solid data points).
"The biologic candidate is not likely to crack the $500 million a year mark (a half blockbuster), in my opinion..." Still, 'nothing to sneeze at.' C'mon, I thought you would've used it before I did! January 29, 2014 at 7:36 AM Condor said...
From 2004-05. . .
Of Direct abdc season 7 Marketing Miscues
More FDA Resources. . .
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The Condor. . . .
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