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It excludes the applicants stop-clock, the time taken by the applicant for responding to the additional information request

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Reconstitution math for the 50 mg 5-Amino-1MQ vial BAC water added 1.0 mL Concentration 50.0 mg/mL 1 unit (U-100) equals 0.50 mg (500 mcg) BAC water added 2.0 mL Concentration 25.0 mg/mL 1 unit (U-100) equals 0.25 mg (250 mcg) BAC water added 3.0 mL Concentration 16.7 mg/mL 1 unit (U-100) equals 0.167 mg (167 mcg) Use 3.0 mL as the maximum BAC-water volume for this 50 mg vial format

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