You're Kidding Me, Cardiome!

Canadian drug developer Cardiome (Nasdaq: CRME) has been waiting nearly four months now for word from the FDA on its lead drug. Unfortunately, the first-quarter results it released earlier this week offer no idea on when that wait might end.

The FDA was supposed issue a decision on intravenous (IV) vernakalant, a potential heart arrhythmia treatment, on Jan. 19. On its conference call this week, Cardiome understandably got numerous questions from analysts about this unprecedented delay. The company could only state that the FDA reviewer has not yet found time to complete the review. In Cardiome's words, "he will complete his review soon," although the company added that it doesn't know what the FDA means by "soon," exactly.

Drug review dates get pushed back all the time, but there's usually a clear reason why -- a request for more clinical trial data, or negotiations over a drug's labeling, for example. Aside from its length, Cardiome's FDA drug review delay is particularly unusual because the FDA has not requested any new data relating to its marketing application, according to the company. Cardiome says the review's delay "seems to be entirely procedural".

Cardiome has its hands tied until the FDA makes a decision. Other drugmakers like Novartis (NYSE: NVS) have sued the FDA in the past, hoping to prod the agency to make a decision on their drugs after longer delays, but Cardiome isn't at this potentially bridge-burning stage yet. Beyond a lawsuit, there's nothing it can do to force the agency's hand.

No matter when the FDA decides to rule on IV vernakalant, Cardiome is still advancing its oral version of the drug through clinical trials. It presented interim phase 2b data for oral vernakalant in March; final data from this study is expected in late June or early July.

Cardiome also is in the midst of partnering discussions for oral vernakalant, and it expects to wrap up these talks a few weeks after releasing the phase 2b data. Of course, the negotiations will largely hinge on those results. But even if the FDA hasn't decided on its lead drug by then, at least Cardiome may have other good news to report.