The UK has about 3,000 new patients a year discovered to have GBM, the US estimate is between 12,000 and 15,000. While it might be reasonable for the UK to have a commercial production facility capable of handling 1,000 patients might be considered adequate for the UK, to say it would be for the US to me is a big stretch. With no plan to build many new tiny cleanrooms I don't believe you have an acceptable facility.
Could the company file a BLA and propose the existing Sawston facility, until the US regulations changed to sealed units I suppose it would have been possible, but would the FDA inspectors have approved it, I very much doubt it. Technically the filing may have been permitted previously, so I won't say the company lied, but I believe they knew what they had to do, and that meant approval to manufacture with the EDEN Unit.
If the US joins the UK in authorizing the hub and spoke model, with approval of the EDEN Unit I believe there are sufficient facilities that with a little training could become spokes that production on approval here could be handled largely by spoke activities. Whether Sawston can serve as the hub for everywhere, or a US based spoke would have to be established is uncertain, but it seems that Pittsburg may be setting up to be a US hub.
Could the company have decided years ago to build say 1000 tiny cleanrooms, I suppose it would have been possible if they could find funding. Now it would be questioned if new FDA regulations would permit them to continue to function, or if they would be forced to convert to sealed units even after they got an approval.
I would suspect that NWBO knew the sealed unit requirement would be coming, though I doubt if they knew it in 2020 when they acquired FlaskWorks. I don't have any idea if this was in the works prior to Trump, or something his team insisted on, but it really is the right way to go.
To me the timing of other approvals is keyed to production. Whether it's the FDA next, or some others piggy-back on the UK approval, until the FlaskWorks EDEN Unit is available, vaccine will be in very short supply. If other countries approve the hub and spoke, I suspect many spokes will rapidly be established rapidly with Sawston designated as the hub. If the demand is there, I believe that FlaskWorks can ramp up production of the EDEN to meet the demand. I believe that contractors are doing the work, but ultimately the monitoring and maintenance on the units would be FlaskWorks responsibility.
Gary
Bullish
Market Data 
Markets 
