Monday, October 15, 2007 10:53:02 PM
Overall this is my take:
Going into the meeting I would have said on a scale of 0-10:
Unable to agree on endpoint: 0
QOL endpt with T: 3-4
T plus/minus metabolic: 9-10
I think what we saw is the buy-in that there needs to be no QOL as it relates to sexual f(x) and the FDA clearly noted the endocrine relationship.
It looks as though RPRX will need to in the quick near term design a protocol with a metabolic endpt and discuss this further with FDA. 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 (hence timing is backed off slightly) BUT on the POSITIVE the potential end market for Androxal just got much larger if there can be a study that more clearly teases out metabolic syndrome and Androxal as a treatment. In Europe they are still home free. Overall I rate this a 7-8 out of 10 as far as my interpretation with what little we have to go on. I will encourage the company when I talk to JP to keep everyone as updated (via cc) as possible as they did with the endo program upon milestones being hit.
Going into the meeting I would have said on a scale of 0-10:
Unable to agree on endpoint: 0
QOL endpt with T: 3-4
T plus/minus metabolic: 9-10
I think what we saw is the buy-in that there needs to be no QOL as it relates to sexual f(x) and the FDA clearly noted the endocrine relationship.
It looks as though RPRX will need to in the quick near term design a protocol with a metabolic endpt and discuss this further with FDA. 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 (hence timing is backed off slightly) BUT on the POSITIVE the potential end market for Androxal just got much larger if there can be a study that more clearly teases out metabolic syndrome and Androxal as a treatment. In Europe they are still home free. Overall I rate this a 7-8 out of 10 as far as my interpretation with what little we have to go on. I will encourage the company when I talk to JP to keep everyone as updated (via cc) as possible as they did with the endo program upon milestones being hit.
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