Tesetaxel FDA Approval Update Tonight? If they keep getting these good results it could get the fast track. imo. How can they get approval when they have not even submitted it to the FDA yet? Before it can be approved- 1. Got to finish the PII trial. (+/- 1 yr) 2. Evaluate the data (3-6 months) 3. Design PIII trial (6-12 months) 4. Conduct PIII Trial (2-4 years) 5. Evaluate the data (3-6 months) 6. Submit the data to the FDA for approval (NDA) 7. FDA has 6-12 months to respond. So do the math and stop posting false information. Someone needs to ask the hypers- "Who do you work for?" Someone like the SEC.