Meirluc, to the best of my knowledge, the approval of an FDA BLA or NDA includes the approval of the commercial production facility that will be employed for the product. In the UK, this facility is approved prior to the submission of the MAA.
If NWBO submitted a plan that showed sufficient capacity to meet demands with manual production, as they did with Provenge, I believe that they could gain approval. I don't believe that it's the direction the company wants to go, but if it's impossible to gain approval to utilize the EDEN unit in a reasonable amount of time, the manual option is not out of the question.
As I've said previously, the inspection and approval of the production facility can come toward the end of the 6 month period established by the PDUFA, so if the company was certain they'd gain approval of the EDEN in a matter of a few months, they could submit their BLA prior to EDEN approval. The entire facility should be ready for inspection by at least a couple months before the PDUFA date to permit some minor corrections and reinspection prior to the PDUFA date. While it would be better to know the EDEN was approved going it, it would be up to the company if they wished to take some risk with an earlier submission.
It's my belief that if EDEN never existed, DCVax-L would be approved and a massive number of cleanrooms would be built for manual production of it. It would be far costlier to produce, employ substantially more highly paid people, require far more construction, but it could be done, and demand for it would be as great, as long as insurance paid for it. It would be profitable, and it certainly will be in the UK with manual production, though I suspect the earnings for each batch will be lower when produced manually than if produced in the EDEN or other similar device.
Gary
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