So, no expanded Gardasil® vaccine population, in the U.S., until at least year-end 2010. Many outlets have this after-market-hours story, tonight, but here is the Reuters version:
. . . .Merck had expected to hear from the U.S. Food and Drug Administration by next week, Merck spokeswoman Pam Eisele said.
"However, the FDA has informed us that the review cycle has been extended," Eisele said. She said the company is continuing its talks with the agency, and expects to hear from the FDA by year end. . . .
This will likely put a crimp in the second half forecast. I suspect this class of women -- 27 to 45 year olds -- on a percentage basis, isn't as likely to be swayed toward the vaccine, as the younger crowd -- but even so, only one-in-three teens get the vaccine, at present, apparently. [The older group is a larger group than the youngsters for whom Gardasil is now approved, though.] I'll keep you posted.
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