AI
Saturday, March 15, 2008 9:41:26 PM
The issue with Androxal is or course the FDA decision to not allow T replacement as an endpoint.
I really call BS on the FDA here. If T replacement is an efficiency endpoint for any drug, then it should always be such. Yes, they could make the argument for stricter safety testing, but that is a seperate issue.
Do we have a rulling (or gut feeling) on the EMEA position here? If they would go for T replacement then the drug should immediately be licensed ex-US. I do think it has more value than some of the nay-sayers imply.
[[[ funny edit, I just corrected the last sentance to add "imply". I could imagine the assults I would have taken if gone uncorrected
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