Friday, June 27, 2008

Delayed

There was all kinds of fanfare, ads and then an expansion of the wonder-drug for HPV, Gardasil. There was talk of expanding it beyond the range of young girls to most women. But turns out the FDA has other ideas. They want more documentation that it's effective.

According to the article,
"Merck said it has already discussed the questions with FDA and expects to respond to the agency in July. Amy Rose, a spokesperson for Merck, said, "Once we go back to the FDA, we'll have a better sense of what the review timing looks like." Linda Bannister, an analyst for Edward Jones, said, "It's hard to get a feel for if this is a dead issue or if this is delayed."

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