What's the only thing more embarrassing for a drugmaker than getting a "complete response letter" for a New Drug Application (NDA) from the Food and Drug Administration? Having the FDA refuse to file its NDA in the first place.
A "complete response letter" is sent after a review is complete and the FDA needs additional information before a drug can be approved. When the FDA refuses to file an NDA, the agency is essentially saying that the drugmaker doesn't have it together enough to get the application filled out correctly.
It usually happens to small drugmakers with less experience about what the agency wants. Acorda Therapeutics
But for it to happen to Merck
The funny thing is, there seems to be little reason to rush MK-0653C's approval. The drug is a combination of Merck's
Then again, considering the glacial speed at which the FDA is moving these days, maybe it's never too early to start the drug approval process.
Is this a one-time slipup or a sign of bad things to come for Merck? Let us know what you think in Motley Fool CAPS. Make an out- or underperform call on these companies or post a pitch about where you think Merck is going. It's free, fun, and Foolish.
Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. Pfizer is a recommendation of the Inside Value newsletter. The Fool's disclosure policy dots its t's and crosses its i's. Wait. Reverse that.