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The advisory committee was set to meet on November 16th, 2016.
However, a week before the meeting, it was abruptly canceled with little explanation provided by the company, other than they were working with the FDA to provide answers to questions that had come up.
To that end, in the beginning of 2016, William Blair analyst Katherine Xu estimated Heplisav's original PDUFA date was in February 2013.
Prior to this, the FDA's Vaccines and Related Biological Products Advisory Committee voted 8:5 that there was insufficient data to support the safety of the product.
The market sensing that things were not going DVAX's way responded by selling off the stock dropping it down to .
The company mentioned that it was going to explore all strategic options including finding a financial partner to shepherd Over the next few months, Dynavax does not find a strategic partner.None of this fazed the market, as the stock kept climbing to over , and this is where it sits as of November 6th, 2017.However, there may be reason to believe that the market is still hedging its bets regarding approval, and this may present an opportunity for an advantageous investment strategy.The third review came in July 2015 with the same positive message.On the back of these encouraging headlines, the stock continued to rise throughout 2014 and peaked near in September 2015.