DVAX says FDA on their side. . But FDA crushes them every step along the way
Now they delay the trial protocol... It's a joke. By the time this pos gets approved their patents will have expired.... Should just go distribute what is left of the cash. Oh and Theodore Cohen and his A Team .. that guy was also bullish on VICAL.... He is murdering people....
I don't think they are delaying the trial protocol. These negotiations take time. Drug companies cannot just snap their fingers and make the FDA jump and give immediate answers.
Furthermore, I didn't invest in DVAX just to have them distribute the cash. If you no longer want to be invested, you are free to sell your shares. You can get more than the value of what is left of the cash.
Snap their fingers? Let's see.. First in a pre-BLA FDA expands the targeted indication from 18 to 70. Then at VRBPAC Panel meeting they don't defend them. Then, despite Dino's reassurance at the JPM HealthCare Conf. in San fran, the FDA deny's them the target indication, denies them a restricted population, denies them CKD and brings up manufacturing issues. Ok then, again despite Dino's reassurances that they are making "progress" and are "encouraged" the FDA comes back and says do another trial. Then with a new CEO who states that he too is "encouraged" and that a new trial design will be arrived at shortly as the FDA wants to bring this to market, 2 months pass and nothing. You realize that the FDA at a minimum is going to ask for a 1 year follow up? This means you need to enroll say 7,500 patients then after they have been vaccinated follow up them up for a year? You are looking at 2017! I think the patent expires in 2020?