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Re: hptaxis post# 221170

Tuesday, 10/02/2018 4:27:21 PM

Tuesday, October 02, 2018 4:27:21 PM

Post# of 252476
>>VK5211

I really don't understand why you see this as a fail. It's incomplete data from a small trial, but nothing they disclosed to date gives cause for concern. You ask about the dogs that didn't bark (like lipids) - that is indeed a legitimate concern, but we have to wait for more data before deciding one way or the other.

This is designed to be a more selective anabolic drug, so there is no reason at all to believe it would do better than a conventional steroid on efficacy. So the fact that the durability wasn't 24 weeks is to be expected based on oxandrolone also not being durable at 24 weeks. Why you conflate that lack of durability with androgen induced hypogonadism I'm not at all sure.

What endpoint the FDA will want is unclear to me. 6-minute walk would be great - very likely they could get efficacy there if the trial was bigger. Fractures would be harder - need a way bigger trial. But FDA going to want reassurance on safety (prostate cancer for one), so this will require a fairly big study anyhow.

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