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Post# of 709766
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hankmanhub

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hankmanhub

Re: Lykiri post# 292265

Monday, 06/29/2020 8:43:26 AM

Monday, June 29, 2020 8:43:26 AM

Post# of 709766
Lykiri and Iwas, just to clarify the process in the UK a little more for those of us who know little about it, what does the UK call their equivalent to a BLA and when did NWBO start this filing? I presume that this is what you are referring to about hearing news before November in response to this filing - I assume that the RA in the UK is the MHRA?

The expected timeline for their answer for approval would be like a PDUFA date? What exactly does the NICE recommendations cover and is that from the MHRA as well, and is this something different than a plain vanilla approval?
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