Tuesday 8 May 2012

PPMD Holds Landmark Meeting with FDA Leaders to Address Trial Design, Endpoint,... -- HACKENSACK, N.J., May 3, 2012 /PRNewswire-USNewswire/ --

PPMD Holds Landmark Meeting with FDA Leaders to Address Trial Design, Endpoint,... -- HACKENSACK, N.J., May 3, 2012 /PRNewswire-USNewswire/ --: "The recent PPMD-FDA leadership meeting provides a solid foundation upon which we can build to develop and implement the tools and processes necessary to expedite the FDA's review of potential treatments and accelerate the delivery of safe and effective treatments to our patients," Furlong said.
"FDA leaders provided valuable information and perspectives on trial design and surrogate endpoint acceptance, two critically important issues, and expressed a desire to continue the discussion with industry leaders. PPMD looks forward to working with FDA to convene a larger roundtable discussion and other follow-up activities on these issues in the coming months, and will work with all patients and Duchenne stakeholders to ensure the community's voice is well-represented at these events."

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