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NVRO<>Nevro up on FDA approvable letter

Recent IPO Nevro (NVRO) moves up on increased volume in response to its announcement that it received a letter from the FDA informing the company that its Premarket Approval Application (PMA) for the Senza spinal cord stimulation system (SCS) is approvable. According the letter, the approval is contingent on the satisfaction of regulatory inspections and audits of manufacturing facilities, methods and controls for Senza as well as finalization of labeling.
The Senza system utilizes low frequency spinal cord stimulation, typically between 40 Hz and 60 Hz, to treat chronic pain such as persistent back pain.
NVRO's chart action today is notable in light of the extended price range, specifically the intraday high of $65.50. This was an opening bell fill of only 2,201 shares. Some unlucky investor either forgot to put limit on his stop order or made the mistake of entering at the market.

Read http://www.nevro.com/ous/physicians/senza-advantages/