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Re: iwasadiver post# 328723

Tuesday, 11/10/2020 3:05:48 AM

Tuesday, November 10, 2020 3:05:48 AM

Post# of 714378
I agree with you iwasadiver, I believe the reason for the delay in the DCVax-L Phase 3 clinical trial data lock was due to all 4 regulatory authorities (RAs) taking longer than expected, to give NWBio buy-in for the revised SAP & the revised endpoints. NWBio patiently waited for all 4 RAs to buy-in, then they announced data lock.

If we look at the SAP guidance we got from NWBio, it says:



NWBio did not do the data lock & unblind the data for the independent statisticians to start reviewing & analyzing until they received SAP & endpoints buy-in from all 4 RAs. I think that is why DI told some callers that “sometimes the government moves slow”.

If you look at the timing & the sequence of events you will see that the data lock PR occurred on 10/5/2020:

https://nwbio.com/northwest-biotherapeutics-announces-data-lock-of-phase-iii-trial/

And the first time we all became aware of the changes to the clinical trial endpoints in the UK & Germany trial registries was on 10/8/2020. That was only 3 days after the data lock PR. That was when I first discovered those changes to the UK clinical trial registry & I posted this message:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=158783215
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