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Re: Omayr post# 100737

Tuesday, 02/07/2017 12:53:15 AM

Tuesday, February 07, 2017 12:53:15 AM

Post# of 703733
Ok. Those were this morning. Farther back than I looked or searched. I think those criticisms should be expected. Others here, including myself have pointed out the same ambiguities. If the lift on the hold is the real thing, then NWBO needs to spell that out.

But let me give an example of a possible reason why they cannot speak about it, (so the halo does not dim for me). Just one of infinite possibilities:

The original hold was due to an apparent PFS futility that was based on dated technology for determining PFS. But the sponsor was still blinded when it subsequently specified a new and improved method, which is in fact universally accepted as more accurate and more appropriate here. That new and improved version was used recently when determining the PFS count, and the FDA learned something about efficacy at the same time, responding, "Holy Mother of God, this is a true miracle. Let us not sit on this struggling biotech any longer, but free it from our errant curse immediately!" And so it was done.

However, the FDA was not speaking out loud above. They just mumbled it to themselves. So the trial sponsor, and all of us, remain blinded.

Although just one of many possibilities, I'm pretty sure that is exactly what happened.
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