Biotech Values

[biomaven0]

>>DVAX

I assume this will be enough to preclude FDA approval

As I commented at the time, I disagreed with this assessment and said the weakness would prove to be a buying opportunity:

FDA Agrees With Dynavax on Consistency of HEPLISAV(TM) Lots

Companies:Dynavax Technologies Corporation
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DVAX 2.43 0.00

Press Release Source: Dynavax Technologies On Thursday July 28, 2011, 8:00 am
BERKELEY, CA--(Marketwire -07/28/11)- Dynavax Technologies Corporation (NASDAQ: DVAX - News) today announced that the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) advised the company that "CBER agrees that clinical consistency of three consecutively manufactured lots of HEPLISAV has been demonstrated." In a written communication to Dynavax, FDA noted that "Although lot consistency criteria were not met at the pre-specified time point of 4 weeks PLD (post last dose), lot consistency criteria were met 8 weeks PLD, the time point corresponding to the primary immunogenicity endpoint, as well as at several other time points."

According to Dr. Tyler Martin, President and Chief Medical Officer, "As expected, the FDA has confirmed our assessment of lot consistency in the Phase 3 trial we just announced. With their concurrence, we can now move forward towards our goal of preparing a BLA for submission by the end of the year for hyporesponsive populations aged 40 and older."