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Posted On: 12/13/2019 12:58:15 PM
Post# of 149993
Quote:
One thing , safety profile for 700 mg must be good , because we know that any serious side effect , they need to report within 48-72 hrs.
Misiu,
Yes, you are absolutely correct. This was submitted earlier and therefore no expectations of "meaningful" SAE's. I was thinking more on the direction of general AE's percentages and how they compare with 525mg.
This can give as a hint of what FDA might be thinking as far a dosage is concerned, in case there is a substancial deviation.
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