Sarepta Expects Final Print Version of Eteplirsen Phase IIb Clinical Study Manuscript Submitted to Annals of Neurology to Include Corrected Images
3:38p ET August 19, 2013 (Benzinga) Sarepta made the following statement:
It was recently brought to our attention that there was an inadvertent error with one of the immunofluorescence staining images included in a figure in the eteplirsen Phase IIb clinical study manuscript, which was accepted for publication by the Annals of Neurology earlier this month. After the manuscript was accepted for review, it was made available online by the journal prior to the review of galley proofs. The journal has been contacted and we expect the final print version of the manuscript to include corrected images. Importantly, the staining images in the publication were intended to be visual representations of the data at different time points. The actual quantification of the data was based on the evaluation of numerous images comprising over a thousand muscle fibers per patient. These data, which are also included in the manuscript body and in separate figures, have been reviewed and confirmed for accuracy.
I have wondered why it takes into the first half of next year to complete the paperwork for the NDA. What have they been doing all these months? There is only data on a dozen kids how many ways can you present that such that it takes 6 months to compile it all? I would think a couple of good data analysts could have it all presented into about a dozen different forms in a month. Bio what do you think of the timeline of it taking into the first half of next year? Why not sooner. It isn't like they are waiting on more test results that haven't been completed are they??? If so what would they be?