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Alias Born 04/06/2017

Re: None

Monday, 06/05/2017 1:19:06 PM

Monday, June 05, 2017 1:19:06 PM

Post# of 106834
At the beginning of the year, we applied for the FDA’s new Regenerative Medicine Advanced Therapy (RMAT) designation for our MyoCell™ product. In March 2017, the FDA reinstated our IND (MARVEL trial) to active status. In May, the FDA acknowledged that they received our additional information and are still in the process of reviewing our application for RMAT. Please note the FDA takes up to 60 days to review information submitted.


So, somewhere in May+60 days...
Just keep waiting.