Advanced Cell Technology, Inc. (OTCBB:ACTC), a biotechnology company applying cellular technology in the field of regenerative medicine, announced that it has received notification from the US Food and Drug Administration (FDA) that the Agency is currently drafting a response to the Company relating to the Investigational New Drug (IND) Application it filed in November seeking clearance to initiate a Phase I/II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardt’s Macular Dystrophy (SMD). ACT is currently on clinical hold pending a response from the Agency, which it expects within the next few weeks.
“We look forward to receiving the FDA’s response and working with them to address any questions that they may have,” said William M. Caldwell IV, Advanced Cell’s Chairman and CEO. “Although ACT has taken important steps to advance our RPE program during the last several years, we anticipate the need for further discussions with the Agency before clinical trials can proceed.”
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Advanced Cell Technology, Inc.