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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Q3 2013 Sarepta Therapeutics Inc Earnings Conference Call


The policy of FDA can not be reasonably explained.

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. 

this is an interesting idea:


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."
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!

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