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Re: flipper44 post# 550914

Monday, 12/19/2022 8:41:08 PM

Monday, December 19, 2022 8:41:08 PM

Post# of 700266
At this stage without any approved products such as approved DCVax-L, it's of course on the legal basis of INVESTIGATIONAL (clinical trials), ie MIA (IMP). The significance for this is that all parts have been checked ok for finally commercial manufacturing authorization issuance pending product approval.

Once after MHRA reviews BLA, the MIA (IMP) wold change to MIA on the legal basis of HUMAN.

So IMO this is what we should get at this stage, and it's as significant as a commercial manufacturing license pending approval of a manufacturing product.

The authorization for investigational manufacturing had been issued last year on 21 December: https://nwbio.com/northwest-biotherapeutics-announces-mhra-approval-of-license-for-gmp-manufacturing-at-sawston-uk-facility/

No need for MHRA to authorize the same thing twice, although with different forms.
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