NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

I couldn’t just let this one go because it’s too ignorant to not address

you were saying something about being ignorant? Tell the MHRA that

Thank you for your email.



We generally require that the commercial manufacturing process intended for the MA be fully qualified, GMP- compliant, and reflected in the Manufacturers License before the MA is granted.



MHRA will typically assess the updated process as opposed to the original, especially if the applicant intends to commercialise the new route.



Timeline impacts are usually considered clock-stops, not backlog.



We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.



The MA must reflect the commercial manufacturing route.



Kind regards,

Aleena

MHRA Customer Experience Centre

Communications and engagement team

10 South Colonnade, Canary Wharf, London E14 4PU
Telephone [phone]