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Hebias

MA Time lines

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Submission date

Potential launch date

Reset
Clock stop day 60 options
Clock stop day 120 options
Procedural Hearing
MEA Options
(only possible with Class I drugs)

Request for CS (and or hearing), request within 20 days after receipt of D60 report

Request for CS (and or hearing) request within 10 days after receipt of D120 report (max. 1 hearing during procedure)

Request for hearing within 20 days after receipt of D60 report

Request for hearing within 10 days after receipt of D120 report

Day

Date

Procedural time to next step;
incl hearing

Abbreviations

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