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Re: skitahoe post# 251667

Thursday, 11/14/2019 1:36:17 PM

Thursday, November 14, 2019 1:36:17 PM

Post# of 687267
It is my understanding that there is no formal approval. Comments, that's what the FDA sends back, if anything. And, DI has said NWBO has been working with the RA's while drafting the SAP. So, I believe they were helping the FDA understand what they will potentially see from the unblinded data based on what they have learned since the trial started. Again, I am hoping the final draft has been in RA's hands for over 60 days, or close to it, which would put us very close to data lock and topline.
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