The Medical Developments International Ltd (ASX: MVP) share price has returned from its trading halt with a bang.
In morning trade, the medical device company's shares are up a massive 32% to $4.50.
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Why is the Medical Developments International share price shooting higher?
The Medical Developments International share price returned to trade this morning following the release of an announcement relating to its US aspirations for the Penthrox (aka the green whistle) product.
According to the release, the US Food and Drug Administration (FDA) has unconditionally lifted the agency's clinical hold on Penthrox.
As a result, this means that Medical Developments International can immediately begin preparing for its Phase III US clinical trial.
The release explains that the trial will be conducted on a targeted trauma and associated pain patient group and is expected to run for two years. The company intends to commence recruitment for the trial in late 2022. This means a long-awaited US launch is now a possibility in the coming years.
Management commentary
Medical Developments International's CEO, Brent MacGregor, was delighted with the news.
He said: "We are thrilled with this news which allows us to move forward quickly with preparations for our clinical trial. After years of hard work, our team is buoyed by the prospect of bringing the many benefits of Penthrox to the US market. This will strongly complement our growing Penthrox success in Europe, and fully supports our further investment in the product."
This sentiment was echoed by the company's Chair, Gordon Naylor.
He commented: "This news is important as it brings Penthrox a step closer to licensure in the US market and because the FDA is seen as a global regulatory leader. Our renewed focus on the core business continues to yield results."
