NorthWest Biotherapeutics Inc (NWBO): RE: PIM next steps. Opinions on the bo...

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Re: Rkmatters post# 20438

Monday, 10/06/2014 7:03:49 AM

Monday, October 06, 2014 7:03:49 AM

RE: PIM next steps.
Opinions on the bolded points?

Step 2
EAMS scientific opinion
? Must have PIM designation to apply
? Phase III data required (Phase II in exceptional circumstances)
? Scientific review by MHRA (assessment of benefit–risk)
? EAMS pre-submission meeting
? Assessment fee up to £29,000

Step 3
National Health Service (NHS) commissioning
? Approval by NHS commissioning board
? Clinical advice from clinical reference groups (CRGs)
? Treatment restricted to specialised centres
? Medicine provided free of charge.

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