Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review
Expediting Availability of New Drugs for Patients with Serious Conditions
Speeding the development and availability of drugs that treat serious diseases are in everyone's interest, especially when the drugs are the first available treatment or have advantages over existing treatments. The Food and Drug Administration (FDA) has developed three distinct and successful approaches to making such drugs available as rapidly as possible: Priority Review, Accelerated Approval, and Fast Track. Because each of these approaches implies speed, there can be confusion about the specific meaning of each and the distinctions among them.
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
There is an application for Fast Track process. You need to be APPROVED for Fast Track status. Hundreds of drugs apply for Fast Track status and do not make it. It requires preliminary study document, advantages vs side effects, ect. It is a couple hundred page application. It does not guarantee acceptance and approval of the drug, but it is 60% of the process if it is approved as Fast Track.
Keep in mind that there is a huge short position in this stock by both retail and funds. Think about the motivation to talk down the stock through providing false information about what Fast Track is. Remember that the market is a future indicator. If they can achieve the other 40% of compliance and results, it will be approved. IMO