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FDA & Sarepta

I am disgusted with the FDA's suggestion to Sarepta that they include a placebo group in their next trial. I wish they could find a way to conduct these trials with out putting our sons through that.

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Permalink Reply by Jason Darienzo on November 12, 2013 at 2:04pm

Q3 2013 Sarepta Therapeutics Inc Earnings Conference Call

http://investorrelations.sareptatherapeutics.com/phoenix.zhtml?c=64...

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Permalink Reply by Peter on November 12, 2013 at 4:21pm

The policy of FDA can not be reasonably explained.

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Permalink Reply by Jason Darienzo on November 12, 2013 at 5:01pm

The FDA is questioning every aspect of a trial setup that they approved.

This is a political decision. Eteplirsen should be judge on its own.

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Permalink Reply by frankie on November 13, 2013 at 5:04pm

this is an interesting idea:

http://tinyurl.com/p5393up

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Permalink Reply by David on June 5, 2015 at 3:54am

Talk about disgusting..
here is an article that, for me, exposes the FDAs true motivation. How long have they insisted on more significant results from sarepta? And yet they'll approve a female viagra drug that the study sponsor themselves admitted was barely there.

Here's the part that made me scream out loud.

"These are very modest results," said Dr. Julia Heiman of the Kinsey Institute at Indiana University. "But on the other hand, even modest results can make a lot of difference when you're at a certain point in the clinical problem."

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Permalink Reply by Chris Diemler on June 5, 2015 at 12:35pm

Agreed David, this makes me ill. We as a community continue to allow the FDA to run rough shot over our kids and us while people and organizations with the clout to bring about change continue to tell us to play by the rules and that change is happening...well I don't see it and time continues to march on towards a fate we are all well aware of. I'm tired of it!