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Re: dennisdave post# 799288

Saturday, 11/22/2025 10:34:13 AM

Saturday, November 22, 2025 10:34:13 AM

Post# of 819974
You’re ignoring that this has been the long term plan all along, and you are lying that it can’t be done the way it was planned. Instead:

In pharmaceutical manufacturing, a company can initially gain approval based on a clinically-used process, then submit a Type II Variation (a major change) to switch to a more efficient, scaled-up process once it is ready and validated. This variation requires submission of new data to demonstrate that the product made by the new (Flaskworks/Grade C) process is equivalent in quality, safety, and efficacy to the product made by the clinical (Artisan/Grade B) process.
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