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Both compounds are long-acting once-weekly molecules, so protocols are organized around a weekly schedule rather than daily dosing
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There's no approved New Drug Application (NDA), no Biologics License Application (BLA), and no Investigational New Drug (IND) application in the public record that has advanced to human clinical trials.[1] Under the FD&C Act, any drug intended for use in humans must either receive FDA approval or be the subject of an authorized IND before it can be administered to patients.[2] FOX04-DRI meets neither criterion
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