C. Michael Gibson MD

@CMichaelGibson Dear Dr Gibson keep the great work. I like it very much and most that i have sent the link of wiki doc, they loved it.

$SRPT FDA adcom audience yelling at panelists - after suggestion of another biopsy

$SRPT Lack of well control seems to be cited most by no voters. Member says we need a placebo trial. Angry audience shouts out in response.

So third strike for boys with #DMD and their families. My heart goes out to them all. Hope companies see their passion, stick with it. $SRPT

There are kids with DMD and their families feeling a lot of disappointment and pain right now. $SRPT.

#FDA Billy Dunn: Emotion/passion in the room is clear; I assure you we listened carefully/take information under serious consideration $SRPT

Q7 $SRPT adcom vote (do clinical results provide substantial evidence etep is effective)? Yes: 3 No: 7 Abstain: 3

Dr. Green of Icahn School of Medicine: My yes vote was impacted by public hearing, still have serious concerns w/historical controls

People now bringing beers into the adcomm meeting room. Wow, that's a first.

.@adamfeuerstein Still full room. Faces not looking happy. $SRPT

Last Q at $SRPT adcom - Q7: do clinical results provide substantial evidence that etep is effective for treatment of DMD?

Panelist asks how much to take views of pt community into account in voting on Q7 (applause) - FDA's Woodcock says there's flexibility $SRPT

$SRPT adcom audience has begun answering panelist Qs en masse

In setback, a majority of FDA experts reject Sarepta’s emotional campaign to gain Duchenne drug OK | FierceBiotech http://www.fiercebiotech.com/setback-a-majority-fda-experts-reject-sarepta-s-emotional-campaign-to-gain-duchenne-drug-ok …

FDA panelist puts blame on $SRPT for not doing a placebo-controlled trial. Company says it's not ethical for patients. But what now?

$SRPT FDA adcom panelist Paul Romitti -- no vote -- says he hit the wrong button, meant to vote yes. So vote should have been 6-yes, 7-no

3 of 5 Yes votes were patient advocates/patient representatives