February 26, 2007
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I hope it would, but I can't guarantee that. But I think that our first goal is to make sure that it's effective and safe and if we can improve that, then we can approach the providers and the insurance companies and hopefully, they would pay for this, make it ADAP approved. But it's a little too early for me to say.
It's a long road, isn't it. Because the other growth hormone is not yet covered by most public or private insurance.
So how will it be different with this one?
I can't say for sure that it would be different, because I'm not the providers, the insurance companies. It's a very different approach, though; even though it's the same end hormone that goes up, it's a different approach. Again, GH is not approved for lipodystrophy. GH is approved for AIDS wasting, okay? So neither GH nor GHRH are approved. GH and GHRH might be considered for approval for lipodystrophy, but they are not currently. When they do get approval, at that point we can assess whether they will be ADAP approved. Right now, GH is only approved for AIDS wasting.
Is there anyone working towards this? Is there anything patients can do, or clinicians can do, to try to get this on the radar?
Well, this kind of interview, this kind of press at CROI. Also, I think that if patients continue to participate in these trials. I think there are over a thousand patients that have been enrolled in GH and GHRH studies. That's probably one of the largest treatment groups of any therapeutic strategy to improve CVD [cardiovascular disease] risk. Unlike other smaller trials of much smaller numbers, you actually pool these studies together and you get a very large number of patients. And hopefully this will be obvious to the FDA in their consideration for approval. We want to help patients very badly. Patients are very interested in this. It was easy to approve this study. It came in easily. So I think they would very much look forward to this if it were approved. And I couldn't agree with you more. I hope it does get approved. I hope it does get ADAP approved. We're working very hard to make that happen.
Is this an ongoing study?
Well, the first one I mentioned is in the extension phase. It will be over in April. The second phase to be studied that -- the FDA requires the second study to confirm the first -- has now just started.
Okay. Thank you very much.
To view study abstract, click here.
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