Warlock, Peter Davis' suggestions, that you brought over here, on why our MAA is taking so long may explain not only the very lengthy time to expected approval in the UK, but also the sudden uptick in movement by NWBO in the US. In the last 6-12 months management has acquired use of a facility in Pittsburgh, hired the person to run the facility, brought to our new facility Dr. Kalinski and his trials ( that we licensed) and is actively hiring other employees. It's almost as if they're getting ready for expansion into the US as soon as possible!
Peter Davis suggests that MHRA may be aligning their regulatory changes and Sawston approvals with the FDA to take advangage of one of several programs, such as Orbis, that allow companies to go for multiple approvals. Peter's comment would also align with Linda's comments in 2023 after a problem was found with the way a consultant prepared our application and the company was forced to change consultants and make last-minute changes in the format, etc.. Linda said that they had to take time to get it right with the UK MAA because they would use this application to apply for DCVax-L approval in other countries.
I also greatly appreciate Peter pointing out that NICE pricing, not MAA approval, is what can't happen before April 28 when the new regulatory pricing and rules take effect, if the company wants to take advantage of the $25,000 increase in price for high-cost drugs, like DCVax. Delays between MAA approval and pricing approval often takes several months, so we don't have to wait until late April for MHRA approval since pricing will likely be delayed until then anyway. (Or pricing can be held until then!)
Thanks again, Warlock!
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