Replies to post #769890 on NorthWest Biotherapeutics Inc (NWBO)

[barnstormer]

Doc, I concur with your analysis "that nobody can hold MHRA accountable to a specific time frame nor will they do so themselves as long as they see the kind of progress being made they want to see". However, on the other side of the equation the folks at NWBO are estopped from making any comments at all about the process or delays because the MHRA will hold them accountable.

[kabunushi]

Doc, the perfect is usually the enemy of the good. Especially wrt GBM, where median survival is so short. For all the improvements in the pipeline, NW can treat 50 patients per month, maybe as many as 1000 in a year, with the artisanal method. Financially, reaching the 1000/year rate would be fantastic, but that doesn't seem like a realistic ask of a ramp. We can only guess on demand growth, but doing 400-500 patients in the first 12 months after approval would be incredibly successful. A more modest 200-300 seems more reasonable start. Even 200-300 could bring $40M-$60M in revenue (subject to timing because I'm pretty sure the billing consists of an initial payment for making the vaccine and then payments by injection). IMO that's great for the first 12 months. I would guess that it's unlikely they can reach max capacity level of demand in less than a year. Either way, the need of the patients is great, hence I doubt MHRA would be motivated to delay approval until a much larger capacity is available. If they are willing to accept the MAA on the merits of the treatment, it's very hard for me to believe that MHRA would delay based on needing to see capacity to treat more than 600-1000 patients per year.