USRM I warned any glitch come CRASHING back down.
Post# of 106709
(Total Views: 574)
Posted On: 03/30/2017 6:14:24 PM
USRM I warned any glitch come CRASHING back down.
Sure enough USRM PR today confirmed FDA needs
additional info. Not a total disaster but it will be 'weeks'
at least for even the possibility of FDA approval can
happen>USRM has to get RAT Designation first
before FDA approval will happen.
SUNRISE, FL / ACCESSWIRE / March 30, 2017 / U.S. Stem Cell, Inc. (USCC) (USRM), a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies for human and animal patients, has applied for Regenerative Advanced Therapy (RAT) designation from the FDA.
Following the passing of the 21st Century Cures Act, U.S. Stem Cell, Inc. has applied to the FDA for RAT Designation. We have recently heard from the FDA, who has requested additional information regarding the MARVEL Phase II/III trial. We have provided all requested information to the FDA and are hopeful that the FDA will continue their expeditious review of our MyoCell product. Thanks to the REGROW component of the Cures Act, the FDA will grant RAT designation for a regenerative medicine therapy that is intended to treat, modify, reverse, or cure a serious or life-threatening disease and demonstrates preliminary clinical evidence that the product has the potential to address unmet medical needs for a disease. We believe that our MyoCell product meets these requirements, as we have demonstrated clinical efficacy in both preclinical and clinical studies, including our most recent MARVEL trial publication (review full publication here: https://www.ncbi.nlm.nih.gov/pubmed/21982657). If RAT designation is granted, this could expedite the approval process with the FDA.
More information on the FDA's new RAT Designation can be found here: https://www.fda.gov/BiologicsBloodVaccines/Ce...537670.htm.
Sure enough USRM PR today confirmed FDA needs
additional info. Not a total disaster but it will be 'weeks'
at least for even the possibility of FDA approval can
happen>USRM has to get RAT Designation first
before FDA approval will happen.
SUNRISE, FL / ACCESSWIRE / March 30, 2017 / U.S. Stem Cell, Inc. (USCC) (USRM), a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies for human and animal patients, has applied for Regenerative Advanced Therapy (RAT) designation from the FDA.
Following the passing of the 21st Century Cures Act, U.S. Stem Cell, Inc. has applied to the FDA for RAT Designation. We have recently heard from the FDA, who has requested additional information regarding the MARVEL Phase II/III trial. We have provided all requested information to the FDA and are hopeful that the FDA will continue their expeditious review of our MyoCell product. Thanks to the REGROW component of the Cures Act, the FDA will grant RAT designation for a regenerative medicine therapy that is intended to treat, modify, reverse, or cure a serious or life-threatening disease and demonstrates preliminary clinical evidence that the product has the potential to address unmet medical needs for a disease. We believe that our MyoCell product meets these requirements, as we have demonstrated clinical efficacy in both preclinical and clinical studies, including our most recent MARVEL trial publication (review full publication here: https://www.ncbi.nlm.nih.gov/pubmed/21982657). If RAT designation is granted, this could expedite the approval process with the FDA.
More information on the FDA's new RAT Designation can be found here: https://www.fda.gov/BiologicsBloodVaccines/Ce...537670.htm.
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