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Wednesday, April 12, 2017 7:38:44 AM
When USRM applied for RMAT designation, MyoCell wasn't in Active Status.
The FDA obviously didn't like that.
So USRM applied for Reactivation with FDA
A sponsor who intends to resume clinical investigation under an IND placed on inactive status shall submit a protocol amendment under 312.30 containing the proposed general investigational plan for the coming year and appropriate protocols.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.45
In short... clinical trials on subjects may resume.
RMAT isn't coming any time soon
USRM needs money to continue their investigational plans for the next year... more dilution. Isn't lack of funds the reason it was shelved 10 years ago?
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