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Re: DewDiligence post# 229410

Thursday, 03/19/2020 12:05:48 PM

Thursday, March 19, 2020 12:05:48 PM

Post# of 257288
From IR:

ASPEN-1 Phase 3 cervical dystonia, Phase 2 plantar fasciitis, and the Phase 2 trials in forehead lines, crow’s feet and upper facial lines are all fully enrolled and dosed.
All subjects in these trials have passed through the primary endpoint timelines.
The only trial still enrolling is the Phase 2 Upper Limb Spasticity. We have drug for that trial.
Given travel restrictions and to ensure proper trial coordination and completion, we are evaluating and implementing risk-based approaches to remote clinical trial monitoring and activities:
For site monitoring, we are implementing remote monitoring to continue oversight of trial sites for our ongoing studies.
For patient assessments, we are evaluating options for remote patient assessment, for those subjects who cannot physically visit clinic sites.
While most employees are working remotely, our manufacturing team is at work. We continue to prepare for an upcoming FDA inspection for the approval of DAXI with PDUFA date of Nov.25.

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