Friday, July 11, 2025 10:33:10 AM
So, did anyone ask the company to explain the MHRA email response from the other day?
Yes, I did ask the company to clarify the meaning of the MHRA’s recent statement, particularly the part that said “the application is with the company.” Here's what I sent to Dave (Northwest Biotherapeutics):
My message to Dave (July 10):
Earlier this week, the MHRA stated that the DCVax-L application is “not backlogged and is with the company.” A copy of this reply was posted publicly here:
🔗
$NWBO received a second email from the UK MHRA from a previous email
— AJW (@ajw02360) July 6, 2025
I send them. Here is the email I received this morning when I asked a follow-up question about the MAA being backlogged pic.twitter.com/zIZx3ypFl0
Following recent clarifications I received from the MHRA regarding when and why the clock pauses during the assessment process (e.g., in the context of inspections or outstanding GxP issues), I was wondering:
👉 Does this wording suggest that the MHRA is currently waiting on final responses, documentation, or clarification from Northwest Biotherapeutics before moving forward?
I completely understand if there are limits to what can be shared publicly, but any context—particularly whether the next move is with the agency or the company—would be very helpful.
Thanks again for your time and openness
And here’s Dave’s reply (July 10):
I would not put any undue weight on anything that is posted on social media. There are numerous new speculative statements made every week it seems .
We cannot comment on the status of our application, but we have stated that we continue to be be fully engaged with the MHRA with regard to our application . I don’t know of any company that comments on an application that is under review.
Best
Dave
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