My sense from JP's conversation, reading between the lines, was that the FDA experts were too unfocused / all over the place to be pinned down to an SPA. It was all a bit too hypothetical for them with the state of the current data in hand and only Repros's assumptions about MoA etc. to go on The right answer was to go ahead and do the trials to remove those hypotheticals. Having proved what they so far have only been asserting about the drug, they will be able to have a very different conversation with FDA.
Repros know they have to collect a ton of safety data and that's what they're doing.
All seems like a sensible business decision to gather a lot more results in a short time rather than sit on hands for months waiting for some delphic utterance from FDA that would probably take forever to fulfill.
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