Replies to post #84008 on US Stem Cell Inc (USRM)

[Lonewolf1]

BINGO

he second draft guidance describes the expedited programs that may be available to sponsors of regenerative medicine therapies, including the new Regenerative Medicine Advanced Therapy (RMAT) designation created by the 21st Century Cures Act, Priority Review, and Accelerated Approval. In addition, the guidance describes the regenerative medicine therapies that may be eligible for RMAT designation – including tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, as well as gene therapies that lead to a durable modification of cells or tissues (including genetically modified cells). USRM intends to take full advantage of this RMAT opportunity and join strategic partners to apply for consideration of its MyoCell product for heart failure patients.


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