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newman2021

08/02/24 11:53 AM

#710242 RE: flipper44 #710237

NWBO can talk about the inspections... it means... there is nothing uncertain about the approval ... and there is no fear of frontrunning the MHRA. Looks like MHRA has given NWBO all clearance for approval. Negotiations for Labelling for both nGBM and rGBM might be going on as well as we speak, imo.
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meirluc

08/02/24 12:17 PM

#710268 RE: flipper44 #710237

Flipper - So 190 days after the January 24 (MAA validation), we are now
only at the beginning of the second phase (80+ days), awaiting the inspections.
I assume that since the inspections have not as yet taken place, no RFI
has yet been issued but that may happen after the inspections. Not
something to look forward to.
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attilathehunt

08/02/24 12:49 PM

#710299 RE: flipper44 #710237

So before Oct 10th....to make it in the 150 day MHRA clock definition.