NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Thanks for the partial transcript senti. It can cause confusion when Linda (and Les last month) say that they believe that the MHRA is following the “150-day pathway,” which has now taken over 150 days since the application was submitted in December, and (I believe) validated in January. I think this simply means that they believe that the application is being processed on the MHRA’s accelerated pathway.

As a reminder, the MHRA created this new 150-day pathway in 2020 after BREXIT, with the intention to further accelerate the EMA’s accelerated assessment of 210 days. Unfortunately, COVID occurred at nearly the same time as BREXIT, which caused regulatory agencies to prioritize COVID treatments which, (along with staffing shortages) created a massive backlog that it has yet to fully recover from. Other than COVID treatments, no application has been processed even close to the 150-210 day timeline. Even though a serious effort to clear this backlog began last year, in January the backlog was over 1100 marketing applications, and it was still over 800 as of April. Last year, Dr. Hopper, the Deputy Director of Innovative Medicines at the MHRA, said that she hoped that timelines could return to 210 days this year.

As Linda described, it has been routine (and expected) to receive information requests from the MHRA during a very active back and forth with the agency during the application review. The company has been anticipating and answering these requests as promptly as possible to minimize any delay in the MHRA’s assessment. I don’t believe that Les or Linda have really tipped their hand to say exactly where Northwest Bio is in the review process; however, the discussion of inspections (and length of time since applying) indicates to me, that the MHRA is likely on the back half of assessment. Nothing that I’ve heard to date, has led me to change my prediction that an approval decision is most likely in the 3rd quarter, but the unknown seems to be the MHRA’s ability to process applications in a timely manner.