Replies to post #691506 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

Why?

Why do I think Phase 2 is always required? Oh, I don't know, probably because the MHRA describes the the accelerated review as a 150 day process, not an 80 day process that may be extended to 150 days.

The MHRA offers a 150-day assessment timeline for all high-quality marketing authorisation applications (MAAs),

The assessment process will run in two phases totalling 150 days

National Procedure (a 150-day procedure) only for high-quality applications to market a medicine in the United Kingdom, Great Britain or Northern Ireland

Notice how it is never referred to as a potentially 80 day process?

Your entire argument that Phase 2 can be skipped is based on your clear misinterpretation of the phrase "if required" in the following excerpt, which is being used to reference the necessity of an RFI/clock off period, not the necessity of Phase 2.

The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required.

"between Phase 1 and Phase II" is an adjectival prepositional phrase that only speaks to the subject complement "(intervening clock off) period" and can be removed from the sentence and maintain context. It describes when the subject complement of the sentence occurs (between phase 1 and 2). It is not itself the subject or subject complement. The statement 'if required' refers to the subject complement. The correct way to interpret this statement is by removing the prepositional phrase "between Phase 1 and Phase 2" and reading it thusly: "The assessment process (subject) will run in two phases (subject complement) totalling 150 days with an intervening clock off period (subject complement), if required".

Your argument for skipping Phase 2 is entirely predicated on your misinterpretation of the English language. There is absolutely no evidence that Phase 2, which is when safety, efficacy, and quality of the medicine is evaluated, is ever just skipped.