No FDA Panel Meeting Seen For Cardiome's Vernakalent >CRME
Aug 1, 2007 12:21:30 (ET)
TORONTO (Dow Jones)--With the passing of a key notification deadline, it looks like Cardiome Pharma Corp. (CRME) won't have to take its lead drug, vernakalent, before a U.S. Food and Drug Administration panel in order to win its approval this fall.
Cormark Securities analyst David Dean said the FDA has scheduled a Cardiovascular and Renal Drug advisory panel to begin Oct. 16, but the regulator would have to give the company 11 weeks' notice if it's required to take part in it.
He calculated that the deadline was Tuesday, and with no release issued from Cardiome, he's assuming it won't have to make a presentation at the meeting, which is just three days before the regulator is expected to make a decision on the approvability of vernakalent, formerly RSD1235, a treatment for atrial fibrillation (abnormal heartbeat).
"The passing of the FDA's deadline for notifying Cardiome that it will have to present its (new drug application) for intravenous vernakalent to a panel of industry experts suggests that the FDA is not going to require Cardiome to do a panel presentation," Dean wrote in a research report.
Dean said such panel presentations happen frequently, and include members of the FDA, the company and industry experts. The company presents its new drug application and takes questions from the panel; the FDA can then ask the panel questions before asking for its recommendation. The FDA typically takes the advice of the panel, but can disagree.
Cardiome initially submitted the application to the FDA in March 2006, but a couple of months later, the regulator responded with a "refusal to file" decision, citing "inconsistencies and omissions" in the database. Cardiome, along with marketing partner Astellas Pharma Inc. (4503.TO), held a meeting with the FDA in July and resubmitted the application in December. It was subsequently accepted for review.
"We strongly believe that this (application) is of high quality, given the efficacy of the drug and the improvements that the overall package would have undergone after the (refusal to file) disaster, so we interpret the passing of the deadline, without notification of a panel meeting, very positively," Dean wrote. "We believe that the FDA is about to approve Cardiome's intravenous vernakalent outright in October."
He predicted Cardiome will confirm that the panel won't be required during its second-quarter conference call, which hasn't been scheduled yet, but is expected in the next three weeks.
Company officials weren't immediately available to comment. |
