NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

I emailed George Zavoico today and got a reply. He said he can’t disclose the exact stage of the MHRA review and never claimed it’s in a “short back-and-forth” phase. What he does say is that NWBO is “actively engaged with the MHRA,” responding quickly to queries, just as stated in the 10-Q. He added the review is taking longer because DCVax-L is first-in-class, but every day of active engagement brings us closer to a decision. He also appreciated the “swallows of Capistrano” metaphor, sharing the same hope and anticipation.

Dear George,
 
I hope this message finds you well.
 
In recent days, several investors have shared on social media that, based on their conversations with you, the DCVax-L Marketing Authorisation Application with the MHRA may now be in a phase characterized by shorter, more frequent back-and-forth exchanges rather than longer, more formal review cycles.
 
As a long-term supporter and follower of Northwest Biotherapeutics, I would be very grateful if you could confirm whether this description is accurate. Many of us understand that, in regulatory processes, such a phase often indicates that the review is approaching its final stages.
 
Some have even described the current atmosphere using the metaphor of the “swallows of Capistrano” — restless short flights and agitation before suddenly departing at just the right time. While poetic, the underlying sentiment is one of hope and anticipation.
 
Could you kindly clarify whether the MAA review is indeed at this stage of rapid detail-oriented exchanges? Any guidance you can share would be most appreciated.
 
Thank you very much for your time and continued communication with investors.
 
Best regards,
XXXXX

Reply from George Zavoico.

Hi XXXXX,
 
Yes, thanks, I’m doing well and I hope that’s true for you as well. Thank you as well for being a long-term supporter of the company.
 
Please understand that I am not at liberty to say precisely where we are in the review process and in that regard I never explicitly said that NWBO is “in a phase characterized by shorter, more frequent back-and-forth exchanges rather than longer, more formal review cycles,” as you put it, or something like that. I typically describe NWBO as being actively engaged with the MHRA, just as our latest Form 10-Q for the second quarter states. That 10-Q also states that the Company and its consultants “devote a large portion of their time in active engagement.” That means that NWBO is responding as quickly and efficiently as we can to their queries and requests for information. That’s all I can say about where we are with the MHRA.
 
I also often add that this review process has been going on longer than anticipated. But given that our technology is a first-in-class and innovative cell therapy that the MHRA has never seen before it appears they are being extra careful in their review. I conclude that given our active engagement with them, every day that passes is a day closer to their decision.
 
I like the comparison you wrote about the swallows of Capistrano! We share the underlying sentiment you mention. We strongly believe in our technology and hope the MHRA does as well and will render a positive decision for us and our shareholders.
 
Cheers, George