NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I don't really believe that's what the company is saying. I think they're saying that production for Europe will come from Sawston, and because this is a new facility it must be certified. You showed that they have a 5 year contract with CRL and that they previously had production capability. I believe they'll be using the CRL capability from the day approval is given for consumption in the U.S., and much of the rest of the world outside of Europe. I believe that the regulators will permit CRL production to expand rapidly to facilities not previously used for production of DCVax-L, just as they would allow any drug maker to expand capability to meet demand.

I cannot say if the FDA today would say the CRL facilities are certified, but I believe that if further inspections were needed, I think they'd say it's just a formality.

I don't know how many clean rooms CRL can say are ready to be dedicated to DCVax-L, but I would certainly hope it's as many or more than what will be ready at Sawston. I don't believe that post approval it will take long before the demand will exceed 1000 new patients a month, if each clean room can produce 4 doses a month, that's 250 clean rooms that will be needed at that time. I believe that 200 of those would come from CRL, and they'll be able to gear up many more in a matter of weeks.

Gary