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Doktornolittle

06/15/16 11:20 AM

#64506 RE: Finding the Truth #64505

"It is very possible that NWBO has about 312 or more patients currently enrolled. Than if NWBO reached 248 events some time this year. Wouldn't NWBO just need the PFS and OS to be greater than the amount given before the resize in trial happened?"

That was my guess from the beginning as to why the screening stopped where it did. That would require sponsor involvement, however... but maybe indirect involvement. Maybe NWBO and the PEI negotiated when the look would occur to evaluate HE reimbursement, and NWBO pushed for the point where 312 were enrolled, matching the required enrollment to reach SS for 6 months PFS advantage, the old bar, as you said.

In that scenario it would be PEI calling the hold on screening, but really NWBO selecting in advance when that hold would occur.

Of course the point in the trial where this data look for HE reimbursement consideration occurs would have to be acceptable to the PEI, but maybe it was. Just a two-fer for NWBO. I like two-fers. I am sure LP likes two-fers. Whether she likes or will like the results of the alleged look... is a different question.