yes totally agree. So if this were to happen would we need...

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dealmein

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15/06/25

12:48

Post #: 79437643
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Originally posted by Bazsa: ↑

Could be even earlier if you take on board the FDA's plans to accelerate the BLA process and the declaration of the opioid epidemic.
IMO there is no reason that clinical use should not transition from P3 trials through to AA and then onto full approval without any period that the product is not available.
As the FDA have noted, much of the review process can be done before the completion of a pivotal trial indeed a BLA probably should be submitted as part of the IND , it would however be a working template, one that could be updated and reviewed by the FDA constantly as new data is added.

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yes totally agree. So if this were to happen would we need increased production processes- this could be a hurdle to jump. 3d bioreactors ????

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