ChatGTP on the presumed back and forward between NWBO and the MHRA:
Yes, it is possible for a back-and-forth exchange to happen in the final stages of an approval process. However, it would be unusual at this stage unless it’s about administrative or post-approval details.
Here’s why:
1️⃣ MHRA has already conducted trial site inspections & manufacturing approval
If MHRA had fundamental concerns about the trial design or data, they would have addressed them much earlier (e.g., during the CHM meeting or RFIs).
Since NWBO hasn’t disclosed any new RFIs, this back-and-forth likely isn't about major trial deficiencies.
2️⃣ Final Stages Often Involve Administrative or Labeling Discussions
Sometimes, regulators ask last-minute clarifications on things like:
Post-approval commitments (e.g., additional safety monitoring).
Labeling or SmPC (Summary of Product Characteristics) wording.
Manufacturing scale-up logistics.
This wouldn't mean rejection is coming—just that MHRA is finalizing details.
3️⃣ The MIA (Manufacturing License) Was Issued After Similar Back-and-Forth
NWBO described a similar situation when the Manufacturing Import Authorization (MIA) was issued.
They didn’t know when approval would come, but after answering all MHRA questions, the license was suddenly granted.
This suggests MHRA is following a similar process for final approval.
Is This Worrisome?
🔸 Not necessarily, but it does mean approval could take longer than expected.
🚨 When It Would Be Worrisome:
If MHRA were asking for new data or trial modifications, that could indicate unresolved concerns.
If NWBO received an official RFI (Request for Information) about fundamental issues, that could be a problem.
If this back-and-forth drags on for months, it might signal internal MHRA debates about DCVax-L’s approval status.
✅ When It’s Not Worrisome:
If MHRA is just finalizing regulatory details (not questioning trial results).
If there are no new RFIs, meaning no fundamental concerns have been raised.
If this process follows the same pattern as the MIA approval (unexpectedly granted after final clarifications).
Final Conclusion:
🔹 It’s not necessarily a red flag—it likely just means MHRA is wrapping up administrative and final approval steps.
🔹 If NWBO is still actively engaging with MHRA and there are no delays, that’s better than radio silence.
🔹 If this extends beyond April with no approval or explanation, then it might be time to worry.
So, I wouldn’t be alarmed just yet, but I’d keep a close eye on how much longer this “back-and-forth” continues.
AI
