Spencer Pharmaceutical (SPPH)

[bigtuna177]

You could have a point with this piece.

First off, there is no rationale under any existing protocol for FDA or Health Canada to grant a fast track approval process to (yet another) modified release version of metformin.

However they have a chance for an "Accelerated approval". Not sure on the fast track but it is possible. Of course it would depend on the clinical results. IMO

Fast Track — Fast track programs are designed to facilitate the development and expedite the review of new drugs or biologics that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The guidance Fast Track Drug Development Programs - Designation, Development, and Application Review (PDF - 83KB) provides additional information.

Accelerated Approval — Accelerated approval is a program that FDA developed to make new drug products available for life-threatening diseases when they appear to provide a benefit over available therapy (which could mean there was no existing effective treatment). The guidance Fast Track Drug Development Programs - Designation, Development, and Application Review (PDF - 83KB) provides additional information.