Chart, page-3840

Fast Track designation:
a) A pharmaceutical company or a sponsor that is manufacturing a drug to treat the condition with no existing therapy can request an application for Fast Track designation. The application can be started at any time throughout the process of drug development. If the drug has significant advantages over existing therapies and the unmet medical need requirement is fulfilled, then also a drug manufacturer must apply the Fast Track designation. After the application, the FDA will review the request and decide within two months based on whether the drug fulfils an unmet medical need in a serious indication.

--> No Existing therapy : NON-AMBULANT DMD Patients
--> Significant advantages over existing therapies... We all know who they are...

What are the incentives for a drug after it receives a Fast Track designation?
After a drug receives Fast Track designation, it is eligible for some specific incentives. These incentives help drug developer to get early approval for that particular drug. The benefits are-

• Regular meetings with the Food and Drug Administration regarding the discussion of the development plan of a drug and to make sure the collection of appropriate information required to support approval of the drug.
• The drug developer could get more frequent written communication from the FDA regarding such the design of the planned clinical trials and usage of biomarkers.
• With the Fast Track designation, the drug can get eligibility for accelerated approval & priority review if all the relevant criteria are met.
• This designation can offer rolling review authorization to the drug company. The rolling review means that a drug developer can submit completed sections of its biologics license application (BLA) or new drug application (NDA) for review by the FDA. The company does not need to wait until every section of the new drug application is completed before the full application can be reviewed.

Once a drug is granted Fast Track designation, early and regular interaction between the FDA and a drug manufacturer is encouraged during the complete drug development as well as the review process. The communication frequency confirms that questions and concerns are settled immediately, often leading to earlier drug approval and access of the drug by patients.

Anything can happen very fast....let alone in share price....we just never know