I don't get Fein's take here. ENCY had an SPA for Thelin. If ENCY was required to monitor sperm count, they would have done so, but the FDA can't now say they want human data having not required it per the SPA, can they? If MYOG is monitoring sperm count and such, bully for them, but Tracleer was approved with just animal studies regarding infertility (with sperm count being one of the parameters). So I think Fein is off-base on this speculation. I very much doubt that ENCY will be required to do trials for approval because of that. I'm a little surprised that post-approval trials or monitoring of sperm count and such in Tracleer patients hasn't been required, but perhaps the population for which this is a real concern is a small one.
I don't know what the problem was for Thelin, but human data for sperm count probably isn't it -- unless they did require and they do have that data and it sucks. But again, it's a class effect, so it should suck for all the ERa makers.
Where's the 18 week safety data for ARIES-1? If I was a MYOG holder, that would concern me more than the relatively weak efficacy numbers.
Regards, RockRat
