Monday, October 15, 2007 11:03:36 PM
>Discussing the relationship further and potentially doing more studies that show a (+) correlation between low T due to pituitary failure and things like high glucose or other wide spanning metabolic abnormalities means two things: on the negative perhaps an additional US study teaing out these relationships prior to the pivotal two PIIIs<
There is zero chance that they would be required to do an additional study *before* the phase IIIs to examine the effects of Androxal on metabolic end points. Metabolic end points are very likely to be included as secondary end points of these studies and/or the primary end point of a smaller study that could act as the foundation of an sNDA and expansion of the market for Androxal.
In fact, I would not be surprised if they conducted a small, quick proof-of-concept study to enhance the sale value of Androxal and left it to future partners to do a pivotal.
There is zero chance that they would be required to do an additional study *before* the phase IIIs to examine the effects of Androxal on metabolic end points. Metabolic end points are very likely to be included as secondary end points of these studies and/or the primary end point of a smaller study that could act as the foundation of an sNDA and expansion of the market for Androxal.
In fact, I would not be surprised if they conducted a small, quick proof-of-concept study to enhance the sale value of Androxal and left it to future partners to do a pivotal.
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