An FDA BLA isn’t rocket science either, just ext
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Posted On: 07/14/2020 11:21:28 AM
Re: Rubraquercus #42885
An FDA BLA isn’t rocket science either, just extremely exacting.
I would offer that none of us have any idea of the challenges of FDA filing, mAb manufacturing, or even distribution, unless we have have personal experience in the mechanism of these processes.
Nearly everything is easy in principle but fiendishly difficult in practice.
What does make it easier is money and the assistance of the experts in these processes. Cytodyn will have those in abundance once trial results are out and the dam breaks. These processes will still be slower than we like, but not the glacial pace we have experienced once FDA and BP are tailwinds rather than headwinds.
I would offer that none of us have any idea of the challenges of FDA filing, mAb manufacturing, or even distribution, unless we have have personal experience in the mechanism of these processes.
Nearly everything is easy in principle but fiendishly difficult in practice.
What does make it easier is money and the assistance of the experts in these processes. Cytodyn will have those in abundance once trial results are out and the dam breaks. These processes will still be slower than we like, but not the glacial pace we have experienced once FDA and BP are tailwinds rather than headwinds.
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