ReNeuron to meet with FDA to discuss issues with stroke therapy
Guildford, UK-based ReNeuron has requested a Type A, face-to-face meeting with the US Food and Drug Administration, confirmed that one has been scheduled for February 14, to discuss its Investigational New Drug application to commence initial clinical trials in the USA with its ReN001 stem cell therapy for stroke.
On January 3, the company announced that it had been notified by the FDA that the IND remaines on clinical hold, with a small number of further issues requiring resolution. One of the purposes of the meeting is to address the issues that have resulted in a clinical hold and clarify the necessary steps to enable the therapeutic development program to proceed.
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