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Re: Evaluate post# 220924

Monday, 04/01/2019 7:51:21 PM

Monday, April 01, 2019 7:51:21 PM

Post# of 700694
I agree... every month is agony... 4, 5, 6, 9, etc., waiting for the damn data. And yes, they note that the last major protocol change took 9 months. But it wasn't any informal opinion as ex suggests... it was a regulatory approval... and that means the RAs allowed it. And my point is if the RAs sign off on the SAP, then they are allowing it.

I haven't forgotten that LP indicated back at the special meeting that the entire process to data lock should not take 8 months... but as we know from experience in NWBO land, time lines change. 8 months beginning in November is June so if October 30, 2018 marked a data freeze, or a soft data lock, and from there they commence the multi-month processes... ASCO has a chance of being on the calendar.

But it looks like timing hinges first on when they submit the SAP, and then how quickly the approvals come filtering back. Or do they return with additional questions?

That's why I think unblinding by ASCO is probably a hoped for goal, but I think we have to be realistic and note that it may not happen by then. Believe you me... I would love for it to happen by then. But I am slowly coming to grips with the idea that it may not.
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