The Food and Drug Administration aims to make a decision on any drug marketing application within 10 months -- six months, if the drug is given a priority review. Many drugmakers hear back on the exact day of the deadline, referred to as the PDUFA date.
Optimer Pharmaceuticals (Nasdaq: OPTR ) won't. The PDUFA date for its antibiotic, Dificid, is Monday, which happens to be Memorial Day. Unless the FDA starts working holidays -- don't count on it -- the company will likely get a decision on Friday, or maybe not until Tuesday.
In the big picture, a few days won't make a bit of difference. While antibiotics from Johnson & Johnson (NYSE: JNJ ) , Theravance (Nasdaq: THRX ) , and others have all had trouble getting past regulators in recent years, I don't see Optimer having much difficulty. Given the generally positive FDA documents, followed by a unanimous recommendation by the advisory committee, an approval seems likely, whether the FDA works to clear its desk for the three-day weekend or saves it for next week.
What kind of label Dificid will get, on the other hand, is still a bit of a mystery. The committee of outside experts split six to six over whether the lack of recurrences of infections was clinically meaningful. Optimer and marketing partner Cubist Pharmaceuticals (Nasdaq: CBST ) would like to have the recurrence data on the label, because it's the biggest draw to using Dificid over ViroPharma's (Nasdaq: VPHM ) Vancocin.
Personally, I think the FDA should just put the data on the label and let individual physicians make up their mind whether it's important or not. But the agency tends to be a little high and mighty when it comes to thinking that it knows what's best for patients -- that is its job, I guess. Figuring out which way the agency will go is a little tough.
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