Turning to some company updates: Cardiome ( CRME) President Doug Janzen told me Tuesday that he and the rest of the company are stumped as to why the FDA has delayed an approval decision for its heart drug Kynapid (formerly known as IV vernakalant.) "We were told by the FDA to expect a decision by 5 pm
Advanced Life Sciences ( ADLS)is another company weighed down with uncertainty. Positive phase III trials for its antibiotic cethromycin should be leading the way towards an FDA filing and a partnership. But both catalysts are on hold for now until the FDA provides more clarity on appropriate trial design and endpoints necessary to garner approval for community-acquiired pneumonia -- the indication that Advanced Life Sciences is seeking for cethromycin. On a conference call Tuesday, Advanced Life Sciences reiterated its belief that the cethromycin trials, as designed, provide the clinical data to support approval. But the company will delay an FDA filing until after the agency convenes an advisory committee meeting April 1-2 to discuss these issues. If the panel doesn't recommend anything that fundamentally alters the regulatory picture, Advanced Life Sciences says it could file cethromycin in the latter half of the second quarter. Partnership negotiations are ongoing, but the company also doesn't expect to strike a deal until the after the FDA meeting. Advanced Life Sciences closed Wednesday up a penny to 81 cents. The stock fell 44% Friday to 84 cents on a Lazard analyst downgrade related to the uncertainty over cethromycin's fate.