Replies to post #550914 on NorthWest Biotherapeutics Inc (NWBO)

[jon_k84]

I am by no means an expert on this, but I believe IMP is the legal basis for authorizing manufacturing. So someone would need to dig into that law and see if that particular legal basis allows for MHRA regulatory submission.

Also, looking at last year's MIA, it's under the same authorization number, but has additional items listed under "Quality Control." So it does seem to imply an inspection/testing was done and new items are now certified.

[Dan88]

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.

[scotty3371]

So smart flipper. One would think extension of old and issuance of new would be clearly defined.