Fast Track Designation...A drug that receives Fast Track designation is eligible for the following:
• More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval;
• More frequent written correspondence from FDA about the design of the clinical trials;
• Priority review to shorten the FDA review process for a new drug from ten months to six months; and,
• Rolling Review, which means Prometic can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.