At current market cap and now clearer direction as to next steps it is pretty evident that next steps will be good news. Ultimately, the drug will get approved, just needs to go through more steps. And once approved pretty easy to be profitable and make great earnings for shareholders. This stock was $5 a share when everyone thought approval would be right around the corner. Now it is discounted $3 so a great buy. The FDA simply is following the review committee's recommendations. Additionally, one of the review committee individuals is biased and has a relationship with a competitor. Can't believe such individual was allowed to vote. Nonetheless, DVAX will move forward and this Hep C vaccine is not the only thing in DVAX pipeline either.
I wish I had your faith with this price.....but I see lots of potential headwinds including general market selloff from 5 year highs, rejection in the short term for EU and the need to get a mandatory 30K 1 year trial that will likely be dilutive to existing shareholders....I see stock price pressure for the next 4-6 months and then brighter days with CKD approval and confirmation of safety for wide use.....
As to the existing trials, there is no evidence of problems so that is good news. As to EU just because the US rules one way does not mean the EU will do the same thing. Fact is people do die from Hep B. Hep B is deadly. While there is an existing vaccine there is a market for better and more effective vaccines.
While the market did not take well the FDA advisory committee's recommendation the fact is that such committee ruled the efficacy of DVAX' vaccine very effective and the vote was strong. That is a very good thing so the issue of simply more testing really is a matter of process. After all the panel did not deem that the vaccine did not work.
Additionally, there is the potential of a buyout from big pharma too. Sure big pharma may wait until the approvals are farther along but big pharma could be willing to take the risk and also simply take under its wing the expertise of DVAX as to its employee base and technologies. Certainly other biotech companies have been purchased recently before complete FDA approvals of their work.