Replies to post #755299 on NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

They ask us questions and we give them answers. One of these days they will run out of questions and then we’ll have approval. When that is we don’t know."

If true that puts paid to the pumping that MHRA is friendly with NWBo or takes having a leadership position or even the dread nature of GBM that seriously.

[jesster64]

In other words, backlog is complete and we are up to bat.

[manibiotech]

"One of these days they will run out of questions and then we’ll have approval"
I sure hope that's not what we are waiting for . It will take very very long time to run out of questions from 1.7M pages 

[learningcurve2020]

Told you all that they’re still in Q&A mode. ✔️. So the company can allegedly tell that to an individual but can’t update with a PR. Got it. All that and you couldn’t get out of him whether inspections are complete or even begun, and nothing on NICE?

[dennisdave]

My son spoke to Dave Innes on the phone today, so this is second hand information. Of course, Dave couldn’t say too much. He seemed to emphasize what happened recently with the MIA certificate; that they had been corresponding with the MHRA… "they (MHRA) asked questions and we would give them answers; this went on for awhile. One day after we had given them answers they gave us the MIA certificate. It was somewhat of a surprise to us. The way we’d been going back and forth with them we really didn’t know how much longer it would be. That’s what it feels like now. We’re actively engaged with the MHRA. There are no delays. They ask us questions and we give them answers. One of these days they will run out of questions and then we’ll have approval. When that is we don’t know."

well that is different from what I have heard and its also not great to hear, if true, that they are still in back and forward about the trial. Kinda sucks actually

[dennisdave]

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.