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biosectinvestor

12/04/23 5:52 AM

#652975 RE: The Danish Dude #652973

Exactly right. I had previously gone down a rabbit hole and determined that the FDA's processes were intended to simplify, not make more complex the process of scaling from clinical trials to commercialization and the automation of manufacturing and had come to that conclusion. They intend to make it easier, especially previously if you did it before approval, as part of the approval process, as NWBO clearly has been doing.

I used to argue that there would be no need for additional clinical trials for Flaskworks introduction because they had measures already created and proven to be appropriate for determining quality and efficacy of the product for each patient and those measures do not change from manual to automated. But I had lost my original due diligence that was hours and hours of digging and subsequent experts here convinced everyone how much more difficult it would be. Your careful, never tiring efforts hit the nail right on the head there with that very clear explanation.

Thank you for your constant and very careful due diligence, TDD!
Bullish
Bullish