Worst case what do you have: FDA asks for another trial of 6,500 patients (the company already stated the data from previous Phase III admissible. The previous trial was 3.500. So you have a new safety trial for 6,500. Now as I stated before, and i will post the link, during the last Phase III DVAX recruited 700 patients in 3 weeks. So they can recruit 1,000 in one month. 6,500 patients could therefore be recruited in 7 months. Is it so hard to imagine DVAX and the FDA come to an agreement on protocol before the end of summer? Could the additional safety trial then commence say in December? If so, then enrollment would be complete by the end of May next year. Moreover, 1/2 of the patients, those recruited in the first 3 months would have received both of their shots and the one year follow up of those would have commenced (they would be a month into treatment -- a month after the second shot. So worst case, by June of next year, enrollment is complete, and the one year follow up for 1/3 of the patients has started. By winter then of next year the company would have interim safety data. Now the company has publicly stated that it cost them 25 million for a study of 2,500. Thus, a study of 6,500 would cost about 60 million. This means, the company could get to interim safety data with the money on hand-- winter of next year. Should that safety data be good, then the company will have no problem raising funds say at 2.50 per share. Sell another 50 million shares at that price and they enough funds to finish the study, file the amended BLA and get to see approval with cash in the bank for a sales team. With a global market of 1.5 billion at 2.50 a share with 250 million shares out the company would have a market cap of 625 million. With approval the company should be 3 times peak sales or 3 billion dollars. You have to think a few steps forward here. Of course another case of Wegners and this is all over. I say buy it and put it away.
So this is how you view "worst case".
1st worse case is FDA says, 30K sample size, the fact that 30K is too much for DVAX to complete is all that was said and this isn't really the FDA's problem.
2nd worse case (only because it does let DVAX live for a while) after sample FDA turns them down again
3rd - 60 million may be the cost of the study but I'm guessing the staff and utility companies will also want to be paid - the burn is not $60 million and they can't let the company get to $1 before the next offering. The offering will be long before approval, it will be as soon as they decide if they can do the next trial
Hey, why stop with 30,000. Why not do a sample size of 100,000. After all, we need to find out if 1 in a 100 million population will have some adverse effects! You have to use some common sense before you try to scare people with a sample size of 30 K. You must be a penny trader and not an investor. Sell it when it goes up a few pennies and repeat!