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Regado Biosciences Announces Clinical Hold Of REGULATE-PCI Trial Following Voluntary Halt Of Trial By Regado

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Regado Biosciences, Inc., (NASDAQ: RGDO) today announced that, further to their decision to voluntarily pause enrollment in their REGULATE-PCI trial, the United States Food and Drug Administration (FDA) informed the company today that a clinical hold has been placed on all patient enrollment and dosing of either study drug in the ongoing Phase 3 REGULATE-PCI trial. According to the FDA, this action was taken to formalize the involvement of the FDA in any decision to re-initiate enrollment and dosing in the trial in the future.

"As announced earlier, we remain blinded to REGULATE-PCI study data and are awaiting the outcome of the full safety and efficacy analysis, including an analysis of benefit/risk ratio, being performed by our Data and Safety Monitoring Board (DSMB). Any recommendation to re-initiate patient enrollment in REGULATE-PCI will be based on the DSMB's conclusions and would always be implemented in agreement with FDA," stated Regado CEO, Dr. David J. Mazzo.

Posted-In: News FDA Press Releases

 

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