lying weasel coward. I just watched his testimony. He twists and turns the data against SRPT at every beck and call without hesitation. Sure he interprets it differently. Even to the point of being obtuse. Watch his testimony and then watch Macdonald's refutation of most of farkas points.
Farkas spends excessive time on the "they could do better if they tried harder b.s." I am amazed the audience didn't boo and laugh at him out loud. How insulting for the patients and caregivers.
What he manages to do, unfortunately, is cast doubt on the data by carefully twisting lies intermingled with facts. On a panel not well versed in DMD and chosen by the FDA the outcome was going to be ugly. It could have been and would have been even uglier if the patients and experts and public weren't giving testimony in the afternoon to prove that no matter how farkas interprets the data--the kids are doing better and that is not just some "other" non-drug reason as farkas claims.
What I got more than anything after watching the FDA presentation is their sheer level of frustration and anger with the company. No where do they admit to yanking SRPT around back and forth on acceptable measures. FDA comes off as petulant and indignant starting with farkas and concluding with Bastings. I believe they feel they were lied to and tricked. From that point on they took a very hard line with the company whether or not the company realized it or not.
At one point, Romitti asks if the drug is given accelerated approval how will they possibly be able to do a double blind placebo controlled trial. Bastings admits thats a good question but provides no answers. Uh Duh!
I am a very long term long and my thinking after watching the entire adcom is that, like most on this board, it all comes down to Woodcock. I hope to hell she can see through the egos in the DNP. I hope she doesn't get hung up on making an "exception". Approve it, end of story.