Two faced data

Shaman Pharmaceuticals Inc. plans to meet with the FDA this month to discuss an NDA submission for its Provir to treat AIDS-related diarrhea, although the company's Phase III trial of the agent failed to show statistical significance on one of two ways of measuring the primary end point of reduced total daily stool weight.

The company believes the important fact is that a regression analysis of the data showed significant improvement over time, which is essential for chronic conditions, even though the study failed to show significance in the reduction in total stool weight from baseline...