Relative to how long it's waited, that is.
Eli Lilly and partner Daiichi Sankyo were expecting to hear from the FDA in June. Then the FDA bumped it to September. And Lilly's been waiting for a decision about whether the agency will approve the blood thinner ever since.
But today the companies found out that the drug will be reviewed by a panel of experts on Feb. 3. As I speculated earlier this month, the drug was likely sent out for review because there's probably an internal debate at the FDA over the risk/benefit balance for prasugrel. The drug clearly works, but the excessive bleeding seen in some patients is reason for concern.
I think the panel will likely give the drug the green light. The harder thing to predict, though, is how restrictive a label the FDA might slap on it, which could hamper sales of the drug. It will be competing directly with Sanofi-Aventis
The slow and underfunded FDA has cost Eli Lilly, Johnson & Johnson
Maybe the agency can set a New Year's resolution for 2009: Go back to its goal of acting on 90% of the marketing applications before their PDUFA dates. That would be a nice belated Christmas present for investors.
Make your own Foolish resolutions in 2009:
Pfizer and Johnson & Johnson are Motley Fool Income Investor picks. To see how dividend-paying stocks can offer both secure income and the opportunity for growth, take a free look at this newsletter with a 30-day free trial.
Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Eli Lilly is a former Income Investor recommendation. Pfizer is also an Inside Value recommendation and is partly owned by the Fool. Reading our disclosure policy won't delay you at all.
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