The United States Food and Drug Administration (FDA) aims to make a decision on a Fast Track designation request within 60 days of receiving it:
Request: Drug companies can request Fast Track designation at any time during the drug development process.
Review: The FDA reviews the request and supporting documentation to determine if the drug meets the criteria for Fast Track designation.
Decision: The FDA makes a decision within 60 days.
Fast Track designation is given to drugs that are intended to treat serious or life-threatening conditions and fill an unmet medical need. The designation results in:
More frequent communication between the FDA and the drug company
Rolling reviews, where the FDA can review sections of a New Drug Application (NDA) or Biologic License Application (BLA) once completed
The FDA also has other programs to expedite the review of drugs, including:
Breakthrough Therapy (BT)
For drugs that may demonstrate substantial improvement over available therapy
Accelerated Approval (AA)
For drugs that fill an unmet medical need and can be approved based on a surrogate endpoint
Priority Review (PR)
For drugs that would significantly improve the safety or effectiveness of treatment, diagnosis, or prevention

Kinda like my kids question, "are we there yet?" Thank you though.

Your NT-PROBNP must be 2000 or higher, you cannot have a pacemaker or CRT-D, and there are other exclusionary criteria.

Sheldon
THANK YOU!
A very thorough answer, as usual.

Many centers in the USA are involved in the trials including my local University of Pennsylvania Amyloidosis Center of Excellence.