The Fast Track was granted last Nov, will it be time to get any feed back as
Benefits of Fast Track designation include:
• Increased frequency of meetings with the FDA to discuss the drug’s development
plan;
• Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met;
and
IMUGENE LIMITED ACN 009 179 551 2
• Regular dialogue with the FDA known as a Rolling Review in support of a New Drug
Application or Biologic License Application
The Fast Track was granted last Nov, will it be time to get any...
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