Replies to post #1868 on Spencer Pharmaceutical (SPPH)

[bigtuna177]

Since you seem to know a lot about this, I would like to see if you can elaborate some on this aprticular comment:

This is already a well-satisfied market niche with no outstanding medical need that can be satisifed by Met4 and not by any other product

Doesn't this product actually have a "NEED" and actually quite a large need?
drug for glycemia control in patients with type 2 diabetes is Metformin

In 2005, people with diabetes were estimated to account for 7% of the US population, or approximately 20.8 million people.3 Of these 20.8 million people, 14.6 million have a diagnosis of diabetes, and diabetes is undiagnosed in another 6.2 million. Approximately 5-10% have type 1 diabetes, 90-95% have type 2 diabetes, and 1-5% have other types. Additionally, an estimated 54 million people have pre-diabetes.

Maybe I am just missing something here. Looking for clarification. TIA

[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.