Food and Medication Administration educated the business that designation of X-22 as an easy Track product could not be granted at that time but, if the business desires further consideration, it should submit a new request for Fast Track designation. All previous smoking cessation studies with VLN smokes including 22nd Century’s proprietary tobacco, including Phase II clinical trials which all indicated efficacy, were independent research and weren’t previously sponsored by 22nd Century under its IND. Mr. Pandolfino mentioned, ‘We believe X-22 will be granted Fast Track status by the FDA after completing our company-sponsored Stage II-B scientific trial because, as in additional Phase II trials with VLN cigarettes, we anticipate X-22 to demonstrate a number of advantages in the following areas: efficacy, safety, convenience and compliance.’..Accounting for a 10 percent loss to follow-up, we calculated that we would have to enroll 790 patients. The calculation of trial power also accounted for a second hypothesis, which was that the function rate at 30 days or discharge for major adverse cardiovascular and cerebrovascular events in the TAVR group will be more advanced than that in the medical group. The details of the power calculation are provided in the Supplementary Appendix. The prespecified population for the principal analysis was the as-treated population, including all of the patients who underwent an attempted implantation .