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Sarepta Therapeutics, Inc. Message Board

  • vskomarovsky vskomarovsky May 10, 2014 9:36 PM Flag

    Chris Garabedian's strong conviction ( From Deutsche Bank Healthcare Conference)

    Chris Garabedian - President and Chief Executive Officer
    I know I am not going to give the number, I don’t give the numbers. So but here is what I would say, we at Sarepta, who have looked at this data from day one with a critical eye have believed that there is a real effect here biochemically, clinically and we are very pleased with the safety profile. So from the beginning when we submitted that first briefing document on the 48 week data back in February of 2013 we were confident that this might warrant being looked at that for an accelerated approval, okay. We have only seen our confidence increase as we have gotten more and more updates on the clinical and safety outcome parameters. Our confidence in our dataset has increased even further now that we spend the last six months really talking to a lot of experts in the field, these are experts in natural history, they are experts in dystrophin, they are experts in pulmonary function, they are just practicing clinicians who see a lot of Duchene and the more we share our dataset with them and get their feedback, what do they think, that gives us even more confidence that our view on the dataset is the right one that this drug is working.

    So our confidence level, I would say, has increased over the time as the data has held up and I would say given the recent FDA communications, I am confident that there is more of an understanding on the FDA's part of this disease of how we conducted the study, of the expert opinions, they have talked to some of the experts directly themselves. And so I think overall, my confidence level has increased over that period, over the last year because of additional data, additional perspectives from experts.

    Sentiment: Strong Buy

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