Published in Medical Letter on the CDC and FDA, December 14th, 2003
Orphan drug designation can be granted by the FDA for treatments that might provide significant benefit to patients with serious, life-threatening diseases that affect less than 200,000 persons in the United States.
"We are pleased that the FDA found our preclinical data and rationale for developing AEOL 10150 as a potential treatment of ALS sufficient to grant orphan drug designation at this stage of development," said Richard E. Gammans,...
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