Shares of Navidea Biopharmaceuticals (NASDAQ:NAVB) are trading up 9% Monday on optimism over a quick resubmission of information in support of Lymphoseek’ approval following a Complete Response Letter (CRL) from the FDA last week. Optimism is being fueled by insider buying, an indication that a quick turnaround and approval of Lymphoseek is plausible, as the company indicated in its conference call after the recent FDA decision.
After submitting a New Drug Application for Lymphoseek – an injected imaging agent for use in cancers – in August 2011, the product’s commercialization was delayed on Sept. 10, 2012 when the FDA cited manufacturing issues that needed to be resolved in its CRL to the company. Shares declined by 25% as the news caused investors to be concerned that it could take months before the product would be reviewed again for approval. The FDA, however, cited no problems with the efficacy or safety of Lymphoseek, and instead pointed to issues with the company’s contract manufacturers. In its investor conference call, Navidea stated that the response to the FDA could be rapid, suggesting that the manufacturing problems may be minor and more general, and not linked specifically to Lymphoseek. With insider buying – the people who know the company best – it would appear that the market is gaining confidence in a rapid resubmission. Any indication from the company with regard to a resubmission and an FDA decision in the near-term could send the shares back up to levels seen prior to the company receiving the CRL.
