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A look back at an article about 40 plus days ago re clinical trial delayIt seems easy for the company to blame others for timeline slips and delays. Already missed October for dosing to start. This article was before the clinical trial talked about was even listed. September 19, 2014 by Seiffert Selected snippets " In an interview today, Garabedian said the Cambridge biotech firm has already begun enrolling the 50 to 80 patients who will be in the trial, but that dosing won’t begin until October or November due to delays “outside the company” with contract research and manufacturing partners." The delay is not expected to affect plans to file for approval of the drug with the U.S. Food and Drug Administration before the end of the year. Garabedian said that one other of Sarepta’s five planned trials will also be slightly delayed. A trial of eteplirsen in the very youngest patients (ages 4-6) will likely begin enrolling by the end of the year, but dosing will likely be in January, he said, about a month later than originally anticipated. The timeline for one trial, however, has been accelerated, he said. The trial of eteplirsen in older patients who are already in a wheelchair will start directly after the large, confirmatory study. |
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