Replies to post #569406 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Without further information to the contrary, I currently believe NWBO misunderstood and is possibly still under a huge twofold sequence misunderstanding regarding the MIA/MAA timing.

I find this incredibly worrisome Flipper. I do not expect LP to know of every MHRA rule, however, if its a mistake then this has caused a delay in submitting for MAA since June until at least the ASM when Advent requested MIA. In my view its, not a mistake. I think LP was deliberately saying MIA is a prerequisite for submitting a request for MAA to cover for delays because she prioritizes the financing and management of the building up of Advent.

I await a related answer to a general question I posed to the MHRA (not mentioning NWBO.)

I have emailed a similar question to the HMRA (I didnt mention NWBO) and this is the answer I got, so dont expect any specific answer.

Thank you for contacting the MHRA.
Please see the guidance notes for applicants and holders of a manufacturer licence
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1116631/Medicines_-_notes_for_applicants_and_holders_of_a_manufacturer_licence.pdf
Please let us know if you have further queries.

The message Lykiri received from MHRA in addition to MHRA’s guidance are incompatible with Leslie Golman’s and DI’s PR discussing MAA prerequisites as it pertains to the MIA.
(Possibly resulting in unnecessary present or future delay)

I agree. LG and DI assertions makes it even more worrisome.

The incompetence with NWBO management level is incredibly worrisome.