Replies to post #555852 on NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

Yes the 2-6 months is my guesstimate.
These are my hand notes on what Linda said:

First and foremost we are focused intensively on preparing application for product approval, laser focus and file as soon as we can. It is enormous undertaking after the trial finishes and after data lock and after the statistical analysis putting together the application together can take entire year. We have been working on portions of is for a year. We have teams of specialized consultants working on different portions. In our case putting the application has some special challenges since it is fully personalized product. The unique patients ingredents tumor cells can vary widely. We also don't have a lot of presidence to follow. We are pioneering quite a bit. What will make the case for regulators. Want to glimpse of what we are working on as we go along. Sheer scale of documentation that goes into the application and support documents that need to be available for inspections. There is a Trial Master file, Batch manufacturing records, patients records, . . . Can be over a million pages of documents.
This is our top priority and laser focus. We have to get the commercial license first prerec. Our time line is to file as soon as we can and will file in multiple places. We will be strategic and be filing in multiple places.

Much of the time it will take is out of Linda's control so she was not going to sign up for a specific time line other than say the application can take up to a year to complete but they have been working on many of the sections for much of 2022. They can not submit it until the commercial license is granted which I am guessing will be soon and likely to happen in the next 1-2 months. I am thinking they probably have a least another 1 to 4 months until the application is submitted IMHO.

[hoffmann6383]

It will be interesting to see how close your 'earliest in September' MIA prediction is.