The FDA has canceled a scheduled advisory board meeting on Basilea's ceftobiprole antibiotic, a move that analysts say makes a quick approval likely. That's what investors wanted to believe, sending shares of Basilea up in hopes that the agency will move swiftly. The FDA, though, gave no reason for the cancellation and the company declined to speculate on what it could mean. The agency granted a standard review of the antibiotic in July.
"Normally, the process takes about ten months," said a spokesperson. "The treatment application was accepted in mid-July." Drug developers have been scrambling to come up with new treatments for MRSA and other infections that have been spreading quickly. But several big companies also exited the antibiotic field several years ago, making it harder to find deep-pocket partners to advance new therapies.
- see this release
- here's the report from AFX