Last week, the FDA accepted Navidea Biopharmaceuticals’ (NASDAQ:NAVB) resubmitted New Drug Application for Lymphoseek and set an April 30 PDUFA goal. Navidea’s submission was met with a Complete Response Letter in September of this year due to third-party manufacturing issues, and Navidea resubmitted the application at the end of October. The company’s comprehensive response and the FDA’s swift action demonstrate that the issues were far from ruinous; resolving safety issues would have been a much longer, more tedious process, and it is important to note that the FDA never required further clinical studies or analysis. The 6-month PDUFA scheduling, a disappointment to many investors, may be a result of a backlog within the FDA. The agency recently delayed Biogen Idec’s (NASDAQ:BIIB) BG-12 PDUFA by 3 months, which sources say was for similar reasons. Lymphoseek is a radiopharmaceutical used in lymphatic mapping procedures, and improves on existing colloid-based agents. The agent does not necessitate pretreatment ahead of screening, and demonstrates improved tolerability and safety.
Investors now have concrete timelines around which to form a trade. Shares of Navidea sold off considerably in the last few months with the FDA’s actions, setting a new 52-week low just last week. The company is in need of a cash infusion, however, and Navidea may move to firm up the balance sheet in the interim through its credit facility with Platinum-Montaur Life Sciences($15M available of $50M). But, NAVB should again begin moving north as the April PDUFA approaches.