Dynavax Technologies Corp. (DVAX), Tuesday announced that the U.S. Food and Drug Administration has issued a Complete Response Letter or CRL regarding the company's supplemental Biologics License Application to include a four-dose Heplisav-B vaccine in the treatment of hemodialysis patients.
In the letter, the FDA noted that the application didn't provide enough data supporting a full evaluation of the effectiveness or safety of the treatment due to the destruction of several data source documents by a third-party clinical trial site operator, the company stated.
Also, the health regulator said that the number of participants in the trial was insufficient to evaluate the safety of the treatment.
However, the biotechnology company added that the letter does not affect the approved indication for the vaccine in the U.S., the European Union, and Great Britain.
Currently, Dynavax's stock is moving down 1.27 percent, to $10.89 on the Nasdaq.
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