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Posted On: 10/26/2020 3:04:50 PM
Post# of 148903
Re: Lee Ron Lemab #63261
Phase 4 studies are post approval studies so by definition they are not needed for approval.
Usually the are for label expansion or additional indications but sometimes they are commitments required as part of an approval.
Phase 3 is what is needed for approval.
IMO
Usually the are for label expansion or additional indications but sometimes they are commitments required as part of an approval.
Phase 3 is what is needed for approval.
IMO
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