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ATLnsider

09/07/23 8:46 AM

#628857 RE: dennisdave #628839

dennisdave, you sound confused. I attribute that mostly to you not being around here very long. Your alias (dennisdave) was born less than 2 years ago, in December 2021. As a result, you may not know some of the history of this board prior to December 2021.

First, SAP stands for Statistical Analysis Plan (SAP), not Special Protocol Assessment. That is a very important distinction.

Second, NWBio issued their datalock PR for the DCVax-L Phase 3 clinical trial on 10/5/2020:

https://nwbio.com/northwest-biotherapeutics-announces-data-lock-of-phase-iii-trial/#:~:text=BETHESDA%2C%20Md.%2C%20October%205,for%20Gliobastoma%20has%20been%20locked.

Three days later, on 10/8/2020, I was the first person on this board to point out that NWBio had changed their clinical trial database in the UK and Germany to show that they would be using contemporaneous external control arms (ECAs) to calculate the overall survival (OS) for nGBM and rGBM:



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

I also provided proof that NWBio had gotten SAP buy-in (acceptance) from all 4 regulators regarding using contemporaneous external control arms (ECAs):

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159462764

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=160348664

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=160657537
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