Theravance and Astellas close to FDA review for Telavancin

According to Reuters, Drug developer Theravance Inc (NASDAQ:THRX) said the FDA’s anti-infective drugs advisory committee may soon meet to review the marketing application for telavancin, an antibiotic for the treatment of Gram Positive infections. Telavancin is partnered with Astellas Pharma.

Forbes comments on the recent investor anxiety and Theravance stock slide as a result of delays in the FDA review.

Most analysts are skeptical but not  Rachel McMinn of Cowen : ”The FDA is now required to refer all new molecular entities for advisory review prior to approval or explain why not in an action letter,” said McMinn, who added that the telavancin review may be “nothing more than what will become routine for the industry.”