ReNeuron Group has provided an update on progress with its regulatory strategy for its ReN001 stem cell therapy for stroke.
On Feb. 14, the Guildford, U.K.-based company said it met with the FDA to discuss and clarify the necessary steps for approval of its investigational new drug application to commence initial clinical trials in the U.S. with ReN001.
The company said it will continue to liaise with the FDA about its approach to make further data acceptable to them, and anticipates that several months will be required to provide all of the data requested, depending on the final study protocols.
In the meantime, the ReNeuron said it is accelerating to make clinical trial applications for ReN001 in certain other territories beyond the U.S. with established and recognized regulatory frameworks. The applications are being made based on recent face-to-face meetings with the regulators in the territories.
The company intends to commence initial clinical studies with ReN001 in the territories ahead of the U.S., should approval be gained sooner in these territories, as soon as later this year.