The EPA level in the blood is currently understood to be the critical factor in reducing patients' TG's...Blood test studies on patients on MND-2119 would take only a few months to analyze and would demonstrate the effectiveness of MND-2119 in reduce TG's, while not depleting cash assets very much...and could obtain U.S. FDA approval for a drug containing emulsified EPA to reduce TG's....A later study could then be instituted to show that patients, who were on MND-2119, had reduction in their CVD's as well as reduction in their TG levels.
Kind of puzzling it seems. One would think that since it is the same active ingredient all they would need to show it that it produces the same blood levels of EPA. Wouldn't think you would need outcome studies. But our bureaucracy never ceases to amaze.
Benefits of the 505(b)(2) Pathway for new formulation
The 505(b)(2) strategy can be valuable to pharmaceutical companies for a variety of reasons. This pathway can alleviate some of the cost and time associated with the traditional full NDA. In addition, utilization of the 505(b)(2) pathway can eliminate the need for most nonclinical studies and extensive safety and efficacy tests. Other benefits may include:
Potential of lower risk due to previous drug approval Faster development and lower cost due to fewer studies needed Potential to qualify for 3-7 years of market exclusivity
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