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Tuesday, December 05, 2006

Watch Out for Those Clinical Trials

P&G made a deal. They told Nastech they would pay them 15 million bucks at the end of a phase III trial that was suppose to be completed by 2006. Then P&G ammended their deal. For some reason the trial is now predicted to be completed sometime in the second quarter of 2007. In the meanwhile they are starting another trial. The 15 million dollar payment is now deferred. Nastech stock is down $2.78 or 14.49%.

P&G initiated a biomarker study in patients with low bone mass to measure blood markers of both bone formation and bone resorption. This is the study that was suppose to be completed by 2006 but is now expected to be completed during the second quarter of 2007. An additional Phase II dose ranging study has been added to the clinical development program and is planned to begin later in 2007. Nastech is now saying that they and P&G believe the additional data resulting from the on-going AND planned studies are important for the FDA regulatory pathway.

They should have thought of that before. But then, they didn't have any phase II data to factor in to the decision. Do they know something about the biomarker study? Why is supplimental data needed and why is the milestone payment deferred? Could this be a "biomarker" equivalent in the Biotech investment world? A marker of pending doom is a delayed trial that results in a restructuring of the kind of data to be presented to the FDA as well as the milestone payment schedule. Seems likely.

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