Navidea Biopharmaceuticals (NASDAQ:NAVB) announced that on October 30th it resubmitted its new drug application (NDA) for Lymphoseek in response to the FDA’s Complete Response Letter (CRL), which was issued on September 10th. (see PropThink’s prior story). In just over 1.5 months, the company has met with the FDA, clarified the issues in the CRL required for NDA submission, resolved the issues, and executed on re-filing the application, supporting management’s claims that the manufacturing questions were minor and expected to be addressed soon. The turn-around by the FDA could be rapid, as the company believes that just the portion of the NDA concerning third-party manufacturing questions will need to be reviewed before a decision is made. The incentive for the agency to make Lymphoseek available is that this diagnostic has significant advantages over currently used colloid-based imaging agents. Advantages include high resolution mapping of cancer in the lymph nodes, lower side effects, and more convenient administration. The advantages of Lymphoseek enable physicians to “stage” patients with metastatic breast cancer more appropriately, which generally leads to better treatment outcomes.
Assuming Lymphoseek is approved in the next couple of months, the company has stated that NAVB and its U.S. commercial partner, Cardinal Health (NYSE:CAH), are prepared to launch the diagnostic shortly thereafter. In a press release Wednesday, NAVB also noted that it continues to advance efforts to market Lymphoseek globally by filing for regulatory approval in the EU and furthering discussions with potential ex-U.S. commercial partners. Analyst price targets range from $5.75 to $7.50 for NAVB following the Lymphoseek setback in September, but a swift resolution could result in those price targets going higher. Ladenburg Thalmann estimates peak Lymphoseek sales of around $450M, so assuming FDA completes its review of the NDA rapidly, and the product receives marketing approval, NAVB could break through its highs seen earlier this year.