This is from early March Politic article - Mark Foley, the President and CEO of Revance, said that in November the FDA deferred approving his company’s only lead drug candidate, a frown-line injection known as DaxibotulinumtoxinA, because it could not inspect the company's Newark, Calif., manufacturing facility.
“Clearly when you’ve spent this amount of time and money trying to bring innovation forward, these delays have a real impact in terms of our ability to make investments and to hire people and on the growth of the company,” Foley said. “Companies like us are in a holding pattern.” Foley said.
DaxibotulinumtoxinA is also in clinical trials for painful neurological conditions involving muscle movement — such as cervical dystonia, caused by spasming neck muscles that cause the head to tilt to one side. He said that the drug’s approval for those types of conditions will likely be delayed, too.
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