The fast track designation saves time on product approval by the ongoing conversations between FDA and the company before final and complete application is submitted. This ongoing communication between the two parties ensures the parts the company is submitting are accurate and foolproof. Which cuts out a stronger chance of the FDA having to reject the application to be revised and resubmitted. Fast Track Des. is also generally required to be considered for a product to be given Priority Review as well. If a product is given priority review, it’s automatically considered as “fast track”. You can think of it as the next step to fast track.
The safety and efficacy data that backs Ryoncil as an amazing treatment is actually what the FDA will be assessing to decide on Priority Review. So you’re right when you say that data would hopefully create an earlier approval period, because that should gain it the Priority Review!
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