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Thursday, January 19, 2012 12:49:35 PM
Nevertheless and paradoxically, I remain very bullish on the science.
In regard to your remarks re FDA meetings, feel highly confident that now that the written iterations are under way that a physical meeting will take place. Cannot predict the ultimate FDA action but the political and scientific underpinnings are there to approve phase III Cotara to treat a deadly unmet need using NIH catheter method of delivery. The SPA is critical because not possible to use a placebo technique when drilling skull. BP will want an SPA in place of "gold standard" randomized test vs placebo. An SPA should insure that even this mgmt could make a deal in Cotara in the same vein that "even a blind pig can find a truffle from time to time." The proof will be in the pudding but IMO Dr. G has been in contact with the FDA on these issues for a long time as well as meticulously prepared his written work. There should be no surprises. I'll take my chances with Dr. G and I don't think the FDA is really in the business of denying a phase III in a drug that has passed all Phase II requirements. All IMO.
Best Regards,
RRdog
PS Really like the math on the NSCLC second line. Plenty of cushion. Look forward to data later this year and further data on NSCLC front line.
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