SOUTH PLAINFIELD, NJ – SEPTEMBER 21, 2010 – PTC Therapeutics, Inc. (PTC) today announced a grant award of approximately $1.6 million from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OPD) to support an ongoing Phase 3 study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF). The goal of the FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy.
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dinsdag 21 september 2010
Food and Drug Administration (USA) stemt toe met verdere studie Ataluren
PTC THERAPEUTICS AWARDED $1.6 MILLION FDA ORPHAN DRUG GRANT TO SUPPORT AN ONGOING PHASE 3 STUDY IN CYSTIC FIBROSIS
SOUTH PLAINFIELD, NJ – SEPTEMBER 21, 2010 – PTC Therapeutics, Inc. (PTC) today announced a grant award of approximately $1.6 million from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OPD) to support an ongoing Phase 3 study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF). The goal of the FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy.
SOUTH PLAINFIELD, NJ – SEPTEMBER 21, 2010 – PTC Therapeutics, Inc. (PTC) today announced a grant award of approximately $1.6 million from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OPD) to support an ongoing Phase 3 study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF). The goal of the FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy.
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