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Dynavax Technologies Corporation (NASDAQ:DVAX) obtained a CRL from the U.S. FDA pertaining it’s BLA for HEPLISAV-B. The concerns posted by the FDA appeared minor. However, the eventual acceptance of HEPLISAV-B is still in doubt.

The highlights

Dynavax obtained a Complete Response Letter regarding its application of HEPLISAV-B as a drug for Hepatitis B. After the CRL obtained by the firm in 2012, the management reshuffle happened. The positive data released for the HBV-23 trial definitely puts into doubt management’s ability to implement on the company’s vision. However, existing shareholders are faced with this dilemma: jump out or stay in for the jump in prices, while many still have money left. This CRL addresses many questions than those talked about previously.

As per the FDA, a response letter offers a neutral and more consistent mechanism to show that initial assessment of an application is closed and they cannot permit the application in its current form. It is not an absolute rejection, far from it, essentially.

The CRL seeks data pertaining to numerous topics, including explanation concerning specific AESIs, a numerical disparity in a small count of cardiac events in a single trial (HBV-23), new evaluations of the integrated safety information base across different periods, and post-marketing pledges.

Dynavax Technologies is not a cash-rich firm. As of 3Q2016, the firm recorded cash and cash equivalents of $109.9 million. The burn rate is nearly $34 million. Moreover, if the burn rate fails to decline, the firm has nearly three quarters worth of funds. In October, the firm finalized a note purchase deal with Deerfield Management, following which Deerfield had accepted to purchase $100 million worth of company’s 10.375% Senior Secured Notes upon the nod of HEPLISAV-B by the U.S. FDA.

If the deal is still applicable, it won’t permit the firm to support itself until the U.S. FDA sanction of HEPLISAV-B. It is dependent on the nod itself and was believed to fund commercialization measures.

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Steve Kanaval: Portfolio Manager/Writer/ Market Analyst Steve began his career in the Trading Pits in Chicago making markets at the Chicago Mercantile Exchange (NYSE:CME) the Chicago Board of Trade and the CBOE in the early 80’s. He ran the Morgan Stanley Derivative Prop Trading for the firm specializing in Index Arbitrage. He continued his career as a Trader/Portfolio Manager for multiple Hedge Funds during the Internet Boom of the 90’s managing large portfolios. Steve is known as an expert in MicroCap Technology Stocks and the emerging Digital Currency markets as a Portfolio Manager for his Family Office. Steve has managed portfolio’s in volatile asset classes for 3 decades as a commodity trader, hedge fund manager and digital currency trader and miner. Steve publishes his views on the asset classes in a public forum and has published more than 10,000 articles simplifying these complex and volatile assets for readers. His work is published on multiple sites including Bloomberg, Equities.com, Hacked.com, CryptoCurrencyNews as a paid contributor. His work includes research, journalism and archived video on important market volatility related to stocks, digital currency and other volatile misunderstood asset classes. He offers a humorous, unique insight and the related back stories and drivers for readers interested in volatility and emerging market assets. Full disclosure Steve is long 25 digital currencies and sits on the board of multiple public companies involved in digital currencies, and owns shares in these companies from time to time.

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