To be clear, that was only discussion of the EDEN approval, not the UK decision on DCVax-L which should come any day.
To me the scrutiny of a machine or process that makes millions of doses of some product should be far more rigorous than a device that makes a single batch of vaccine for a single patient. Applying years of testing, or even many months for that matter, seems extreme for a device that makes four batches a month. If all observations and tests say the vaccine made in the EDEN is essentially identical, or perhaps even purer, than what's made manually, it ought to be sufficient as long as the EDEN operation is monitored and determined to be functioning properly. I believe that each EDEN unit is connected to computers and fully monitored for proper operation, but I don't know that for a fact. I believe that FlaskWorks should be monitoring every EDEN Unit put in operation and every unit should be their responsibility to maintain and update as necessary.
Gary
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