Sunshine Biopharma Inc (SBFM)

[RainerRocks]

Accelerated Approval Requires .....

"In some cases the Phase II studies reveal results so impressive that these studies alone are the basis for approval, generally for treatment of refractory disease. This is often done under FDA's accelerated approval rule (similar to the fast-track provision under FDA's Modernization Act of 1997 [FDAMA]) which allows FDA to approve drugs on the basis of a surrogate endpoint (effect on a measurement such as a tumor size likely to lead to a real patient improvement) on condition that post-marketing studies demonstrate a tangible patient benefit. In most cases, if Phase II studies show desirable responses, Phase III studies are conducted. Those are concurrently controlled studies in which two therapies are compared. These usually are 1) a comparison of standard treatment alone, or 2) a comparison of the new treatment alone with an older treatment to show that the new treatment is not worse than the older treatment or is its superior."

http://www.fda.gov/NewsEvents/Testimony/ucm115209.htm

We haven't started Phase 1

Phase 1 and phase 2 need to be completed for any Accelerated Approval.