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BIOChecker4

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BIOChecker4

Re: plexrec post# 141931

Wednesday, 02/21/2018 10:35:05 AM

Wednesday, February 21, 2018 10:35:05 AM

Post# of 458359
The Rett IND must have been filed in late October or early November at the latest, based on the carefully crafted language in the 12/11 PR. If I'm right, it's now been about 4 months since the filing was made. It is highly unusual for so much time to go by without clearance to start a trial. I know personally of only one other incident where clearance was delayed for so long, and that was Geron about 10 years ago when they were looking to start clinicals for their spinal cord injury program using pluripotent stem cells. At that time, FDA's concern was for the possibility of developing teratomas. That delay lasted about a year.
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