InVivo Therapeutics (OTC:NVIV) announced a push-back on its time-lines for enrollment in a clinical trial examining its spinal cord injury treatment, a move that brought NVIV shares down by nearly half today.
InVivo announced that, under the terms of its FDA investigational device exemption, each trial patient must be followed for 3 months and the company must win agency approval before enrolling the next, meaning it will take InVivo an estimated 21 months to enroll its 5 patients.
Then, the company plans to launch a pivotal study in order to apply for FDA approval to begin selling its biopolymer scaffolding under a humanitarian device exemption. The delays could push back commercialization for a few years, according to analysts at Seeking Alpha.
"We remain fully committed to beginning this study as soon as possible," interim CEO Michael Astrue said in prepared remarks. "While the study will take additional time, we look forward to bringing this important therapy into the clinic."
The announcement came just a day after InVivo announced the sudden departure of chairman, CEO & CFO Francis Reynolds, who resigned late last week, citing a "medical condition."
NVIV shares dropped to $1.96 as of about 3:45 p.m., down 43.2% on the day.