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Wednesday, February 12, 2014 8:07:35 AM
One way the vaccine can affect OS is by the destruction of the cancer cells. The second way is that it can make it easier for the patient to overcome the toxicity of the chemo.
I believe these are separate, and that either one by itself will improve OS. But the combination of the two could greatly affect OS.
In terms of the DMC recommendation, it's important because I think it's almost impossible to get an early halt to DCVax-L based on PFS alone. There's no reason for the DMC to act and put themselves in the hot seat by recommending early approval if no one's life is at stake.
However, if the OS numbers are through the roof, on top of good PFS stats, that changes things for the DMC.
So it all came together for me yesterday to the point where I concluded that while still not the most likely outcome, the odds of an early halt are greater than I originally thought. Going into yesterday, I would have said 5%. Now I'm thinking 20%. That's big enough for me to want to have a larger position. So I added a few shares yesterday.
I'm hoping that even with a "continue", that we'll get some additional information soon on the enrollment - so we can get a sense of when the 2nd review might occur. That assumes there will be a second review. :)
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