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Sunday, March 20, 2022 3:26:06 AM
Having a factory operating this early and capable of potentially earning substantial revenue hardly constitutes a lack of urgency. The regulatory process is not theirs to expedite and announcing TLD is not necessarily a sign that things are moving more quickly. It can be, but in a case of such complex regulatory process management, all things may be more likely to be getting managed to come together fairly concurrently, and your lack of an ability to see that or know it very likely is a part of a prudent management strategy rather than a “lack of urgency”. I have not seen typically a single product drug company set-up to potentially earn substantial revenue prior to approval before. Maybe that is something you see all the time, if so, please provide examples.
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