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Re: skitahoe post# 524990

Wednesday, 10/26/2022 12:12:23 PM

Wednesday, October 26, 2022 12:12:23 PM

Post# of 724630

Before I saw your post I was about to write one on why going to the regulators is taking so long but it is all here. I don't care how quickly you can do all the paperwork, until you have an approvable production facility you can't do a thing.



Can you show me the MHRA regulation that stipulates the (Flaskworks) production process should be (completely) finished/certified before a marketing authorization of DCVAX L can be submitted? There is no such regulation. MHRA reg clearly stipulates that the company must be able to clarify how it is planning the production of the production it seeks marketing approval for. So if NWBO is holding up the submission of the marketing approval for DCVAX L then the reason can not be MHRA regs for NWBO can clearly indicate/outline its path to near future mass production.
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