Wednesday, September 12, 2012

FDA cancelled its approval for Navidea Biopharmaceuticals (AMEX:NAVB) cancer imaging agent

Navidea Biopharmaceuticals Inc(NYSEAMEX:NAVB) had declared late Monday that FDA has cancelled the nomination for Lymphoseek, a cancer imaging agent as FDA has found that there is some discrepancy with the manufacturing of the said medicine, which has been described as “3rd party manufacturing”. 

However, on behalf of Navidea it has been declared that the company is taking hard initiative to work with FDA in order to resolve the said manufacturing issues and accordingly after getting the concerned issue resolved, Navidea is planning to re-submit the application for getting another review of the said product.

The declaration has made a great impact on the stock value of Navidea which has been increased to 37.3%, which is amounting to $1.31 and has stuck to the price of $2.29 by aftermarket trading value.

However before we try to extract more on this commercial dispute let’s take a look on Lymphoseek to understand its significance for treatment of cancer disease. According to Navidea it is a radioactive imaging agent being in use for determination of spread of breast cancer melanoma up to the lymph nodes of the patient. As per Navidea this radioactive agent can identify the unusual lymph node which is being drained from a primary tumor growth. Identification of these lymp nodes may help for controlling the intensity of cancer spread as these lymph nodes are the main points wherefrom carcinogenic disease gets spread in patients’ body.

Michael King, a Rodman & Renshaw analyst has expressed his opinion about Lymphoseek that the administration of this medicine seems more effective than older version of imaging agent. He said that use of this new imaging agent will be effective in detecting malignancy in tumor for 8 million cases worldwide. King has also added that Cardinal Health Inc has been selected for marketing of this new imaging agent worldwide and as one of the biggest marketer of radiopharmaceutical products nationwide, it is going to make big with this new invention.

Shares of NAVB slumped 25% to $2.64 on Tuesday.

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