Saturday, September 27, 2025 2:33:16 PM
yes, that actually makes a lot of sense.
If George mentioned that pulling data from the German site during an RFI took longer because it wasn’t fully electronic, the August update on the EU registry could very well be the administrative reflection of that process being completed.
It would mean that all that additional data is now fully reconciled, submitted, and part of the MAA exactly what we’d want before MHRA makes a precedent-setting decision. This is exactly why we’re likely close to the finish line now.
IMO this German data reconciliation might not only have delayed MHRA approval, but also perfectly positioned NWBO to file with EMA immediately after UK approval making this a truly global launch moment
If George mentioned that pulling data from the German site during an RFI took longer because it wasn’t fully electronic, the August update on the EU registry could very well be the administrative reflection of that process being completed.
It would mean that all that additional data is now fully reconciled, submitted, and part of the MAA exactly what we’d want before MHRA makes a precedent-setting decision. This is exactly why we’re likely close to the finish line now.
IMO this German data reconciliation might not only have delayed MHRA approval, but also perfectly positioned NWBO to file with EMA immediately after UK approval making this a truly global launch moment
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