NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

HAS THE MHRA POSTED ANYTHING ABOUT THEIR PROCESSING OF THE MIA APPLICATION , PRed BY NWBO on 7/6/22?

https://www.biabrexit.org/static/51d380df-daff-4407-abc046d73a106eb7/MHRAGuidanceFAQ08022021.pdf

https://nwbio.com/northwest-biotherapeutics-announces-filing-of-application-for-license-for-commercial-manufacturing-at-sawston-uk-facility/

ae kusterer

Thursday, August 18, 2022 8:51:34 PM

Re: None

Post#
506289
of 506566
If the "awaiteds "occur in the next few weeks, what's the size of the short position looking down that gun barrel ? Low side:350 million ; high side 1 billion (Larry Smith and The Mathematician)

Awaited: journal(nature, science, Nejm, Lancet, JAMA?),maa application filing, MIA approval, UCLA combo results, JV for 10 solid tumors in combo trials( Keytruda/CI/ DC Vax L/ Poly ICLC; $500 million upfront cash-20% royalty ) , crl global manufacturing agreement, fda bla filing, SPPP , Flaskworks approval.


Re: Lykiri post# 505953

Post#
506004
of 506126
THANKS, Lykiri

"Wednesday, August 17, 2022 4:36:46 PM

Re: ae kusterer post# 505931

Post#
505953
of 506003
Quote:
Is MIA approval required before the MAA application can be filed ?

ae kusterer,
No.
Quote:
Nov.1, 2021

"You are correct that a facility manufacturing an ATMP must have a current GMP Certificate to manufacture either an IMP(material for clinical trials) or an MA product.
If the facility is in the UK or EU it must also hold either a Manufacture Import Authorisation MIA or a Manufacture Import Authorisation for Investigational Medicinal Products MIA(IMP) depending on what product is being manufactured. If in the UK the facility/company must apply to the MHRA for an MIA or MIA(IMP) and this process could take 90 days, during which time an inspection will also be carried out at the facility. Depending on the time taken to close out the inspection and issue the GMP certificate/s this may be longer than 90 days especially if there are any issues found at the inspection. This 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. 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."

Richard Parker
Senior GMDP Inspector
Inspection, Enforcement and Standards
MHRA, 10 South Colonnade, Canary Wharf, London E14 4PU"
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