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Aeolus Pharmaceuticals announced it received a fast-track designation from the US Food and Drug Administration for AEOL 10150.
Aeolus Pharmaceuticals (OTCQB:AOLS) announced it received a fast track designation from the US Food and Drug Administration for AEOL 10150.
As quoted in the press release:
“We are pleased that the FDA has granted Fast Track designation to AEOL 10150 for the treatment of Lung-ARS following a radiological or nuclear event,” said John McManus, President and Chief Executive Officer of Aeolus. “There are currently no approved treatments for this syndrome and we are not aware of any other compounds in advanced development for this unmet need.”
The purpose of Fast Track is to get important new drugs to patients earlier. It is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical. A drug that receives Fast Track designation is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as more frequent meetings and written communications with the FDA to discuss development plans and design of proposed clinical trials.
Click here to read the full press release.
Source: www.marketwired.com