NorthWest Biotherapeutics Inc (NWBO): iclight, It is not accurate to sugge...

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SkyLimit2022

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SkyLimit2022

Re: iclight post# 606863

Wednesday, 07/05/2023 1:58:31 PM

Wednesday, July 05, 2023 1:58:31 PM

iclight,

It is not accurate to suggest that there have not been any submissions to regulators. Most notably, the MIA was approved and is evidence of a regulatory filing plan that has begun to unfold. Further applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. The announcements of regulatory filings are forthcoming.

March 2023

https://cms.mhra.gov.uk/mhra/mia/uk-mia-54923

The MIA is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.

“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA

https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html

https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers

Bullish

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