Wednesday, May 17, 2017 11:28:30 PM
As of May 2017, the Company had not yet met certain milestones under the license agreement. On May 11, 2017, after discussions with NIH, the Company received a letter from NIH stating that it remains NIH’s intention to re-establish meaningful development timelines with the Company once the Company has received further guidance from the Food and Drug Administration (the “FDA”) on the Company’s clinical path forward for Proellex®. NIH has indicated that it understands that the Company had a guidance meeting with the FDA and is waiting to hear back from the FDA once the agency consult with its internal liver experts. The NIH indicated that, consequently, the NIH does not consider the Company in breach of the license agreement at this time.
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