NorthWest Biotherapeutics Inc (NWBO): Types of submissions There are three di...

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NorthWest Biotherapeutics Inc (NWBO)

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Re: exwannabe post# 664924

Wednesday, 01/17/2024 3:25:40 PM

Wednesday, January 17, 2024 3:25:40 PM

Types of submissions
There are three different types of submission depending on the timelines between the FDA and MHRA.

Type A
(Marketing) Applications should be submitted concurrently or near-concurrently (within 30 days) to FDA and MHRA. These are termed Type A Orbis (Regular Orbis) and allow for maximal collaboration (between countries) during the review phase….

https://www.gov.uk/guidance/guidance-on-project-orbis

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