Shares of Navidia Biopharmaceuticals (NASDAQ:NAVB) could trade higher today following a positive update from the company last night regarding the potential approval of lead product candidate, Lymphoseek. NAVB announced that the FDA has granted the company a Type A meeting to discuss the complete response letter (CRL) for Lymphoseek, Lymphosek is an imaging agent that can map lymph nodes in cancer patients, and on September 10, the FDA delayed its decision for approval due to manufacturing concerns. Importantly, the FDA cited no problems with the safety and efficacy data backing Lymphoseek’s application for approval. A Type A meeting generally takes place within 30 days of a CRL, and implies that the FDA is comfortable speaking with a given sponsor without the need for significant preparation. In line with NAVB’s comments that the CRL issues are likely to be resolved quickly, the Type A meeting should make investors feel even more comfortable that this is the case.
The company has stated that after the October meeting, the FDA could complete its re-evaluation of Lymphoseek within the next 6 months, suggesting that an approval by year-end or early 2013 is quite possible. Given FDA’s comfort with the clinical data behind Lymphoseek and the market need for the product, it appears that once the agency is satisfied that the manufacture of the agent is compliant, approval will be granted. Brokerage firm Think Equity raised its price target for NAVB this morning on the news. Expect shares of NAVB to trade up today and continue to rise in anticipation of a potential approval for Lymphoseek in the coming months.
