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Re: Gus1212 post# 294021

Wednesday, 07/08/2020 8:26:09 AM

Wednesday, July 08, 2020 8:26:09 AM

Post# of 723668
Yes. The EC approval is really proforma as once CHMP (EMA) approves a drug it is always approved by the EC. The extra 1-2 months is part of the reason why the EU is generally slower than the US. In this case the indication (front line gBRCA pancreatic) was approved in the US 6 months ago.

This is the approval (MMA) for UK also. EU approval are grandfathered till at least end of year. Still has to make it on the NICE guidelines. NICE has the guidance project listed with a TBD date.

Will be waiting to see when the first cancer drug gets through UK's MRHA approval in the post Brexit world. My guess is not until H2 2021 or later.
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