Replies to post #569068 on NorthWest Biotherapeutics Inc (NWBO)

[StonkMaster]

Thanks Lykiri

[dennisdave]

Thanks

This application (MIA) can be made at the same time as the MA application so long as there is an intention to manufacture product at the manufacturing site. However, it should be noted that the processes are independent of one another and an MIA and or GMP Certificate must be in place for the manufacturing facility before the Marketing Authorisation can be granted.

I just come to show that the MHRA is not really familiar with companies applying for MIA first and letting the MAA wait. Most biotechs would want to apply for MAA asap. As I said here a few times time now. Its a huge mystery to me why Linda thinks/tries to convince us at the ASM the request for MAA can only be made AFTER the MIA is granted and not "at the same time as the MA application" (June 2022).

[eagle8]

Thanks for sharing Lykiri.
As always.

Best to you.

[flipper44]

Lykiri,

You realize, of course, the response you received from MHRA, if true, would make NWBO’s comment, that commercial MIA authorization is a prerequisite for an MAA submission, a fiction.

Here is the relevant part of the response you received.

This (MIA) application can be made at the same time as the MA application so long as there is an intention to manufacture product at the manufacturing site.

Richard Parker
Senior GMDP Inspector
Inspection, Enforcement and Standards

MHRA, 10 South Colonnade, Canary Wharf, London E14 4PU

() are mine

I await an answer from the MHRA to confirm this.