Replies to post #790151 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

During my conversation with George Z he mentioned issues with getting data out of the Germany trial site during a RFI….something about things not being electronic. He said it took much longer than expected but did say the got w HR at they needed and back to the MHRA. I wonder if update at the German site has anything to do with what George mentioned?

Only question I have, is it George Z or Smitty who is blowing smoke on this conversation?

[dennisdave]

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