Replies to post #49496 on NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

My understanding is that the mystery of where the massive expenditures are going is solved with the assumption that it is going to a mfg build for large scale production.

For me that is an acceptible assumption as long as eyes and ears remain open for info and arguments to the contrary.

A further assumption that I have been comfortable making is that the reason for the scale-up now is either because there is some chance of an early approval, or they need to start now to have it fully funtional and approved by the time the FDA and EMA are considering approval. The demonstrated ability to mfg is a consideration for approval, and it may have been communicated to LP that it is a large consideration.

It could be a much longer effort to scale up mfg than myself and others have suggested in their posts. It could be a year long effort, an 18 month effort, or more. I don't know when they started spending the big $. Six months ago?

Gambling $100M+ with such an expansion makes sense to me. It increases the odds of approval and odds of early commercial success if approval is granted. (I also see now why Flipper was talking about the advantage in maintaining skilled staff etc at the clinics and mfg facility.) The whole trial was a huge gamble. This is no different in my view.

[antihama]

However, remember that other drug companies/ immunotherapy companies prepared manufacturing and in some cases guessed right, and in others guessed wrong

Isn't it more than a guess? Reading beachlifeisfun's post 49350 I get the sense that NWBO can figure out whether it's a good idea to expand manufacturing

I believe that when NWBO said that they have had no access to data, they meant no access to blinded data or the efficacy analysis...you can bet your A$$ that they know the enrollment rate, whether and when a patient has progressed, whether the patients that progressed chose to cross over and how those crossed-over patients faired compared to those that chose not to cross over (if any). They likely know the GBM subtype of each patient. Whether a patient is alive or dead...QoL of the patients, immunohistology, MRI data, etc. etc.