Hi Jimmy and Leroy,

The press can be a bit like a game of "telephone," with inaccuracies getting
magnified. One story said it was American (instead of Indian) researchers,
one headline said the trial was "successful" rather than being reopened...

For the straight scoop, you can go directly to MCIP's original press release
(which these stories are all based on). The link is

http://www.eurekalert.org/pub_releases/2006-03/mcip-nmc032906.php

The short answer is NO, human trials are not starting in the U.S. right now,
they are reopening in India (and unfortunately, non-local men are not
eligible, because of the strict follow-up that is necessary if the study is to
meet
FDA standards).

Prof. Guha is working to arrange a collaboration with a U.S. group on animal
studies, though, and should be submitting a grant application with them in
less than a month. We'll be looking for lots of activism at that point--
letters to let policymakers know how much of a priority it is to get things
moving
in the U.S. Right now, the more people who can take a moment to write to the
decisionmaker in India (as described in the newsletter), the better. The
pressure is really on now to make the RISUG to FDA standards and to train the
clinical trial coordinators in India so that the data management will also meet
all the FDA's requirements. We want to make sure that once preclinical
(animal) studies are done in the U.S., the Phase III trial won't need to be
redone!
That will make development more affordable, and speedier too.

- Elaine Lissner
Director, MCIP

==========================================================
In a message dated 4/5/06 12:47:16 PM, lcapasso@... writes:


> WHOA. Do you have a link for this information? I will have a plane ticket
> bought the second I can confirm if I can take part in this. Or are you
> just suggesting that you WISH it would be going on trial in the Northern
> US? (your eMail subject did not include a question mark if this is the
> case)
>
> -Leroy
>
> > This sounds like it is on the right track for a male conterceptive. I
> > would be willing to be a test subject in a trial if one was offered in
> > the Chicago land area. I have had chidren and now in my 50's and still
> > very fertile, so I was tool by my doctor when I rectly had a sperm
> > count done . This is a long time comming and I wish this would of been
> > closer in the 70's.
> >
> > thanks,
> > Jimmy
>
>



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