Replies to post #27653 on US Stem Cell Inc (USRM)

[4toSchool]

FDA Approval Timeline.

Firstly, we don't know for certain if USRM filed for approval using the new designation category created as part of the 21st Century Cures Act to allow drugs to be eligible for designation as a regenerative advanced therapy (RAT). - See more at: http://www.raps.org/Regulatory-Focus/News/2017/01/20/26651/FDA-Begins-Accepting-Regenerative-Therapy-Applications-for-RAT-Designation/#sthash.yeqalNeU.dpuf

Secondly, assuming that USRM did file, we don't know the exact date of their filing. The FDA states that "No later than 60 calendar days after receiving the designation request, FDA’s newly created Office of Tissues and Advanced Therapies (OTAT) will notify the sponsor if the designation has been granted. - See more at: http://www.raps.org/Regulatory-Focus/News/2017/01/20/26651/FDA-Begins-Accepting-Regenerative-Therapy-Applications-for-RAT-Designation/#sthash.yeqalNeU.dpuf

Assuming that USRM did file under the RAT program, I wish that Tomas would issue a press release stating the date of the filing.

Thirdly, we don't know if the FDA will actually be able to meet their 60-day commitment.

http://www.raps.org/Regulatory-Focus/News/2017/01/20/26651/FDA-Begins-Accepting-Regenerative-Therapy-Applications-for-RAT-Designation/