1. First of all, last time I looked at my RPRX material, in some past presentation or CC, the Distress endpoint was referred to (or illustrated as ? not sure) as a required Secondary Endpoint in the Androxal program - so if true it would not be the Primary Endpoint.
2. However when I spoke to Joe P approx one month ago, I had not checked my notes on this presentation, so I did not ask this question. And yet he stated to me that it was a key issue, and if he could get the FDA to put it aside, he may only have a single pivotal phase III trial remaining.
3. Finally there is Nebido by IDEV (I think it's IDEV), and their Phase III has a bio-chemcial endpoint, and they are filing the NDA.
Yes I know this doesn't really help, but at least most of the pieces of the jigsaw are there.
"....on the biotech battle-field, you need some élan...."
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