Research analyst, medium-term horizon, biotech, small-cap

The FDA Should Have Approved Probuphine, But They Didn't... So Now What?

Editors' Note: This article covers a micro-cap stock. Please be aware of the risks associated with these stocks.

Shares of Titan Pharmaceuticals (NASDAQ:TTNP) have been stuck in a narrow trading range between $0.45 and $0.65 for the past 4+ months following the surprise decision from the U.S. FDA to issue a complete response letter (CRL) for Probuphine back in late April 2013. We call this decision by the FDA a "surprise", because only five weeks prior to the decision, in March 2013, the FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) voted to recommend approval of the product. Titan plans to request a meeting with the FDA to discuss the issues raised in the CRL in the next few weeks....

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