Replies to post #814283 on NorthWest Biotherapeutics Inc (NWBO)

[RRP60]

Marauder, i agree with all of this. If this drug is for a covid kind of situation , will they take this long to decide. If the mhra thinks this kind of drug’s processing will take forever, as its an uncharted territory drug,  then they should be upfront about it and company could have tried another country. Our existence is depending on this decision and every day they delay, it will kill a patient and ruin the company before it even start.The trial results are valid , the relevant medical community and key opinion leaders in this  field validated the science. Do you think a couple out of touch family practise doctors and a name sake oncologist in mhra will know more than the practising neuro onc community. The whole processing is a joke if their priority is to save some gbm patients from death with new treatments. Just because there is no accountability in mhra, they can get away with their inefficiency. There are no major side effects to this drug and for petes sake people are living after they take their shots. What more do they want, an additional ivermectin.  I apologize for my uncivilized and ignorant rant.

[skitahoe]

I liked the verdict, if it's true, wouldn't you think the EDEN Unit will be included in the approval. I believe that if it is, under a hub and spoke organization, existing facilities qualified to be spokes should be able to establish agreements with NWBO to do so and initiate making DCVax-L as soon as they've been provided with and trained on the use of the EDEN. The hub would be Sawston regardless of whether it was producing manually or with the EDEN's. I'd add that I see no reason why at least a couple or more EDEN Units can't be operating in the tiny Class B cleanrooms used for artisan production. Production would be doubled if only 2 EDEN's could be supported in each room, but I suspect more than that is very possible.

Gary

[MarauderWarlock33]

I share you frustration RRP60. I post this message as MAA approval delay looking in an one aspect but there are few items that I don't agree with unless the company has change their understanding btw MHRA that the MAA is not contingent on Class C lab automation nor revised and or new pending the clinical trial governing regulations to become law. I believe the approval is over due just based on 70 days decision making period after the second CHM meeting on the past NOV. 27/28. I strongly believe that the approval should be any day now.

[beartrap12]

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!