Mast Therapeutics, Inc. (MSTX)

[mentorman]

Read This; This is not normal FDA Approval, much shorter.

The Company plans to file an NDA for both of these drugs based on the provisions of section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act.

Section 505(b)(2) allows the FDA to approve a drug on the basis of data in the scientific literature or data previously cited by the FDA as the basis for the approval of related drugs. This procedure makes it easier and potentially faster for drug developers to obtain approval of new formulations of drugs based, in part, on proprietary data of the developer of the original drug. The relatively low number of required patients and the single-dose treatment cycles associated with these bioequivalence trials decreases study timelines and costs relative to typical pivotal studies. Accordingly, with relatively modest financial investment, the company was able to assess the pharmacokinetic equivalence of each of their product candidates to the reference product in as little as 12 to 18 months, which information should provide the clinical data necessary to support the NDA.

By securing in advance FDA agreement regarding their planned regulatory pathway, as they have done for ANX-530 and ANX-514, they mitigate aspects of the clinical and regulatory risk associated with drug development. Furthermore, if and after they obtain marketing approval, they can conduct additional clinical studies while marketing those products for use in new indications or to expand product labels in ways that might increase their commercial value.