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ACR16 - Huntexil

Posted by lavonne 
ACR16 - Huntexil
May 06, 2010 01:43PM
EHDN has posted a revised ACR16 update of the European ACR16 trial:

[www.euro-hd.net]

What do you all think about this?
Re: ACR16 - Huntexil
May 06, 2010 02:20PM
I followed the link, and clicked on the first PDF "revised...May 2010...."

It SOUNDS like the author of the report is hopeful that the revised data will NOT affect the speed of approval, and was clear to write the report stating many times that it is still clear that the drug works and seems safe.

But that the first dialog with approval agencies is scheduled but has yet to occur. So I guess I'll feel better once that happens.

And also hopeful that the North American study produces results that are statistically-significant enough to allow approval to proceed here too. (Plus maybe news of the N-Am study can slightly strengthen the case for approval in Europe too).
Re: ACR16 - Huntexil
May 06, 2010 02:34PM
[www.hdsa.org]

Which I posted last week.
Re: ACR16 - Huntexil
May 06, 2010 03:22PM
Sorry -- my mistake.
Re: ACR16 - Huntexil (Independent Review)
May 07, 2010 11:38AM
EHDN investigators to provide an independent review of the ACR-16 results:

[www.euro-hd.net]

Robi Blumenstein
CHDI Management/CHDI Foundation
robi.blumenstein@chdifoundation.org
www.chdifoundation.org
Re: ACR16 - Huntexil (Independent Review)
May 07, 2010 03:51PM
Thanks Robi, this is good news.
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