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Posted On: 03/30/2017 5:47:14 PM
Post# of 235
Been watching USRM for a while and will be taking a position at some point. But need to find out IF there is a PDUFA date associated with Myocell.
Here's everything you want to know about Regenerative Medicine Advanced Therapy Designation. It can take up to 60 days from date of filing for the FDA to make its final decision. This does not mean Myocell is approved, only that it gets RMAT designation.
https://www.fda.gov/BiologicsBloodVaccines/Ce...537670.htm
https://www.fda.gov/downloads/Drugs/GuidanceC...358301.pdf
http://www.fdalawblog.net/fda_law_blog_hyman_...ation.html
Here's everything you want to know about Regenerative Medicine Advanced Therapy Designation. It can take up to 60 days from date of filing for the FDA to make its final decision. This does not mean Myocell is approved, only that it gets RMAT designation.
https://www.fda.gov/BiologicsBloodVaccines/Ce...537670.htm
https://www.fda.gov/downloads/Drugs/GuidanceC...358301.pdf
http://www.fdalawblog.net/fda_law_blog_hyman_...ation.html
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