Dallas, Texas 02/24/2014 (FINANCIALSTRENDS) – The $347 million market capped bio tech firm Dynavax Technologies Corporation (NASDAQ:DVAX) disclosed on 18th February that it has made a decision to seek the withdrawal of its pending application which lying in front of the European drug approval authorities for its fully developed vaccine named HEPLISAV, designed to treat hepatitis B. The decision to withdraw the “Marketing Authorization Application” was arrived at by the development stage drug maker after scrutinizing the list of “outstanding issues” provided by the European Medicines Agency as part of its 180 day review process of the drug target.
It is of import here to note that the European Medicines Agency is the U.S Food and Drug Administration in Europe and the decision to withdraw the application by Dynavax Technologies Corporation (NASDAQ:DVAX) means that the drug maker has decided to go back to the drawing board to work out the issues that are being red flagged by the drug maker. The time lines provided by the European agency to the drug maker to provide additional information was deemed too limited by the drug firm to collect the additional data and hence decided to withdraw the drug.
As part of its press communiqué to disclose its decision to with draw the application, the drug maker had indicated that the European Medicines Agency had concluded that the data provided to support the safety aspect of the drug candidate HEPLISAV was too limited to determine if it was risk free of inducing any other adverse impact in the patient being treated by the test drug. The drug maker indicated that it would commence full-fledged clinical trials of the trial drug HEPLISAV to collate the sought after data by the drug agency. In spite of the developments, the stock is trading currently at $1.08 per share.