The Medical Developments Ltd (ASX: MVP) share price is up 7% or 41 cents to $6.20 today after the company behind the Penthrox pain-killing medical device provided investors an update on its Holy Grail-like quest to get approval for the device in the U.S. healthcare market.
Back in August 2018 MVP shares crashed when it effectively got told by the FDA that its investigative new drug (IND) application would be put on hold as the regulator required more clinical evidence about the safety and efficacy of Penthrox prior to its potential approval for commercial use in the US.
Today MVP's CEO stated that he expects the company will submit its full response to the FDA's concerns by the "first quarter" of 2020 after MVP was provided more details about what the FDA requires at a mid-June 2019 meeting.
MVP also revealed it has agreed to undertake an animal study that tests the safety of Penthrox and expects it will take 6 months to come to a conclusion.
Investors can expect the shares to remain volatile given the uncertainty around the FDA's final verdict on the 'green whistle'.
