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Re: exwannabe post# 677802

Monday, 03/11/2024 2:23:32 PM

Monday, March 11, 2024 2:23:32 PM

Post# of 692405

Different processes means once they vetted the device to go with they will need to run comparability trials to establish they produce the same DC-L. And those are clinical trials. Zero chance they would be ready to submit Flaskworks for use in commercial mfg of -L this year,



There is no level of certainty to what you are claiming here, Ex.

My reading of NWBO's statement is that the process differences described are Flaskworks1.0 vs Flaskworks2.0 vs Flaskworks3.0 differences. Not Flaskworks vs current manual process.

I think it is still very safe to assume that NWBO is seeking regulatory approval of Flaskworks as a manufacturing process for DCVax-L without additional trials; and also, that they have a realistic chance of doing just that.

Either way, it surely cannot be said with any degree of confidence that this is 100% not the case and additional trials are a certainty. Far from it.
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