Q. What differentiates MS-325 from conventional MRI imaging pharmaceuticals? A. Conventional MRI imaging pharmaceuticals, commonly referred to as extracellular contrast, leak rapidly from the bloodstream into the extracellular fluid. As a result, imaging must be completed within seconds, which limits their application and often requires multiple injections for visualization of multiple vascular regions. By contrast, MS-325 binds to serum albumin in the blood, providing a bright image of the blood vessels for an extended period of time, and is safely excreted by the kidneys. Thus, MS-325 enables longer data collection times, yielding a comprehensive set of high-resolution images without the technical challenge of scan timing as conventional contrast flows throughout the body. After a single injection, this intravascular imaging pharmaceutical has the potential to enable a survey of many vascular regions in one MRI examination.
so if these are the facts, and it seems pretty straight forward, why is the FDA breaking the company's balls, if the contrast agent works and is better than anything out there and no one can die from it, have a heart attack or anything bad come from using it etc.....sorry i just do not get it.
FDA wrote the 'approvable' letter asking for more data to clarify the advantage of serum-albumin-binding and gadolinium-enhancing MRA over other techniques. There are many applications for MS-325 based MRA, from vessel plaque and tumor detection to diagnosis of sexual malfunction. The company has another agent for blood-clot detection as well. Foot-dragging by FDA is inexcusable to shareholders at this time.