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No Surprise: FDA Rejects Dynavax Hepatitis B Vaccine

By Catherine Shaffer
Staff Writer

Tuesday, February 26, 2013
The FDA's complete response letter (CRL) for its Heplisav hepatitis B vaccine was no surprise to Dynavax Technologies Corp., of Berkeley, Calif., as it had extensive behind-the-scenes conversations with the FDA between the November advisory committee meeting and the CRL issued over the weekend.

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