Biotech Values

[DewDiligence]

From POZN’s 2011 10-K:

http://www.sec.gov/Archives/edgar/data/1059790/000114036112014567/form10k.htm

In 2012, the FDA requested that we perform an additional Phase 1 study to assess the bioequivalence of PA32540 to EC aspirin 325 mg with respect to acetylsalicylic acid (“ASA”). Enteric coated products such as PA32540 and EC aspirin 325 mg have highly variable pharmacokinetics. As a result, there is a risk that this Phase 1 study may not demonstrate bioequivalence. However, if successful, we believe that by demonstrating bioequivalence to a marketed aspirin product, our PA product will likely receive the appropriate cardio- and cerebrovascular secondary prevention claims of aspirin. We have initiated this additional Phase 1 study and anticipate filing an NDA in 2012.

Was there discussion of the additional bioequivalence study on the recent webcast?