Replies to post #776356 on NorthWest Biotherapeutics Inc (NWBO)

[Mr.reveulto]

reaching the end

So when you expect the decision??

[attilathehunt]

So yes I believe the MAA was submitted for glioblastoma. But the structure of the label may have evolved during review to match how the product is already being used.

Since you appear to be a reasonable person and have a command/understanding of the complications of the application, let me ask you a few questions...

1) Do you believe the approval decision on DCVax-L, will be more than glioblastoma?
2) Do you believe approval will also include EDEN as the go to for manufacturing?
3) Do you sense news, on the franchisee(s), will be announced shorty after approval (within 2 weeks)?

I realize no one knows for sure, however, I am curious on what you think, since I believe much of the delay is due to fact that the MHRA opened up a "can of worms" when they began reviewing the Specials data. I also believe, that is why we had 2 acceptance dates (January for glioblastoma and March for the Special's data). This may also explain why there were 1.7m pages. An extreme amount of information to digest and understand...And once the MHRA dug deep, they realized they needed guidelines on RWD because of the Special data and needed SI 2025 No. 87 to become effective to allow EDEN to move forward. I understand that many will say impossible because the company never updated, however, they did say they will not comment on anything until a decision is made. Lots of moving parts. A very dynamic situation. If all true, it would make sense to remain silent until the final verdict. Lots of "what ifs" so best to remain silent until D-Day.

If it is easier for you to apply a percentage, versus a yes or no, that will be okay.

Final note: It is difficult for me to comprehend this long delay without some far reaching moves. People are dying and perhaps the delay may resulted in people not being able to utilizing the treatment straight away, however, expanding the treatment and/or increasing the number of patients to be treated may in the long run save many others. I am at a loss, in seeing the delay in any other way.

Thank you for your input. Greatly appreciated.

[attilathehunt]

Slave1,


Did you see my post 776374?