Pharma Blog Watch

Approvable Letters Don't Have to Be Bad News (Eye on FDA)
In his blog, Mark Senak features an audio interview with Adam Feuerstein, senior columnist at TheStreet.com. The two discuss FDA advisory committee meetings, such as the one that took place late last month to address Dendreon's investigational cancer immunotherapeutic Provenge, and approvable letters. Specifically, they talk about the effects on company stock of such actions by the FDA.

In the case of Provenge, Dendreon's stock rose following a positive recommendation by an FDA advisory committee. Other factors in play were the fact that Provenge is a first-in-class therapy and that it is for treating prostate cancer, which is a large market.

The two also talk about approvable letters, which Feuerstein calls "one of the great mysteries of the drug business." Approvable letters can cause stock to either rise or fall, and the outcome depends on the conditions the FDA outlines in the letter — whether it asks for additional clinical trials or just label revisions.

In general, companies should be very open in communicating the outcomes of advisory committee meetings and the contents of approvable letters, they conclude.