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Re: Rkmatters post# 36587

Wednesday, 06/17/2015 7:54:43 AM

Wednesday, June 17, 2015 7:54:43 AM

Post# of 732718
I never said I was negative on the trial. I believe I said I was neutral on Ph I. Optimistic on Ph II. I believe they will build on Ph I, and that even the most pessimistic view on that data will be good. That said, it doesn't take away that Ph I preliminary results may not be enough to entice a bigPharma collaboration sooner verses later. If we hear of a partnership soon, that will give us more clarity on the Ph I missing variables.

We now know that Direct Ph I may have run into issues creating enough vaccine for some Ph I patients and may have contributed to not enough patients receiving their full treatment. If this is the case, it is quite possible that certain patients are much further behind on their injection schedule and we may see a few more vaccine graduate moves. I would suspect that is the reason that NWBO amended the enrollment criteria to look for patients in slightly better health to make the leuk draw process a bit less constraining. If they run into similar leuk draw issues as Hodges described in Ph I it may make it difficult to adhere to even a closer injection schedule called for in Ph II. But, at the same time I suspect that accumulating enough treatment to administer may not be as much of an issue considering we also learned that they plan to use 2 mm cells, verses 6 mm or 15 mm, which was used in Ph I, tied along with the fact that they'll seek slightly healthier patients. So let's just pretend it affected 10 patients in Ph I due to the 6 mm or 15 mm cell draw, in theory it should affect a mere fraction of patients in this next phase. But the only flip side to that, is now that we know of this Leuk draw hindrance, we can not rule out that it has the potential to both extend phase II timeline and injection capability in some patients. Again considering they plan to use 2 mm cells, it seriously should be less of an issue in Ph II and it is another reason we should expect to see more robust results in this next phase. Why? Phase II will not only be building on lessons learned from Ph I efficacy, it will be addressing the kinks which this leuk draw is.
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