Thanks Roman,
It's clear that you know a great deal more than I do about the FlaskWorks unit. Do you know if the cassette needs to be loaded and unloaded in a clean room, or is something less permissible.
Hopefully the units will be approved before we reach the PDUFA date here in the U.S. I have a feeling the FDA won't be satisfied with the production we can achieve with clean rooms. The U.K. and perhaps Europe might be satisfied with the clean room capacity from Sawston, etc. on initial approval. I would hope that all 4 regulators have agreed on a single criteria for approval of the FlaskWorks unit and it's approval will apply to all of them.
I feel reasonably certain that NWBO has lined up the capability to mass produce the FlaskWorks units, but I don't know if they've invested in building many of them before they have regulatory approval. As I see it, after approval the company will need to decide if they wish to have these units centralized, perhaps in the hands of contractors responsible for the process, or distributed, perhaps in major hospitals and research facilities capable of handling them. Control could be maintained by the handling of each cassette. I know many disagree with me, but I rather like the idea of distributed processing, I believe many of the worlds major hospitals and research facilities have cryogenic and clean rooms capabilities and they could easily accommodate several FlaskWorks units essentially putting the units just a few hundred miles from those who don't yet have that capability.
To my way of thinking, if in reality the FlaskWorks unit is capable of programming to make many different products as new personalized products are developed, the idea that the units can be distributed and used to make many products is a thing of beauty as NWBO is paid for every use. Of course they'd be paid far more for DCVax-L as it's their product, but wouldn't it be great to be paid for products developed by many other companies.
Gary
