Mate I'm not sure you understand English the FDA Fast...

Mate I'm not sure you understand English the FDA Fast Designation process or both.

To be eligible for the fast track program, an applicant must submit a request with supporting documentation for fast track designation for the product and its proposed use. The FDA is required by the statute to decide within 60 days of receipt of the request whether the conditions for fast track designation have been met.

The FDA then either APPROVES OR DENIES their application. Therefore Imugene has APPROVAL for A FAST TRACK DESIGNATION. This in no way constitutes approval for the marketing or sale of their drugs. That comes later should clinical endpoints and other criteria be met. If their application for fast track designation had been denied they would have received a FAST TRACK DESIGNATION REJECTION LETTER, as opposed to an APPROVAL LETTER.

Stick to the Simpsons, it seems more up your ally. Leave the Imugene commentary to people who actually know how the regulatory approval process works.

WMHB