Wednesday, January 01, 2014 12:19:25 PM
The more I read, the more I am convinced we will see results as expected from the DCVAX-L trial. Because of this, and the fact it is easier to show statistical significance early with PFS as the primary endpoint, I'll stick to the notion the trial will be unblinded at the first or second interim review. I think PFS will be 24 months or more (I do not expect the typical phase 3 falloff -- based upon reasons I gave in earlier posts.) Because of the limited shares outstanding, I expect the company will need to split their stock immediately after the results/unblinding is announced.
I expect a sporadic but relentless price increase as early DCVAX-Direct patient results are released, and I expect another split when the Direct phase 1 and 2 results are shared later this year. After digging down into the history and research, I expect to see an 80% to 100% response rate, depending on the type of cancer. I also fully anticipate seeing indications of complete, systemic and lasting immune responses (again, depending on the type of cancer). I see the phase 1 and 2 Direct results persuading the FDA to approve a large but expedited phase 3 double-blinded trial. I think that trial will be unblinded at the 1st interim analysis in early 2015.
(Prior to the two events above, I anticipate DCVAX-Prostate will be partnered with a large pharmaceutical company. That will likely take the stock above $8.00.)
If the above events all occur in 2014, and they never split their shares, I think the value could range between 200 - 400 per share. After that, I believe the share price would continue to rise and split throughout 2015.
Its still biotech, so don't bet the farm. Stay well within your risk tolerance and means.
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