Shares in Medical Developments Ltd International Ltd (ASX: MVP) tumbled 19% to $4.71 today after the group warned that "the clinical program for Penthrox to be approved for sale in the USA is to be put on hold pending a letter outlining outstanding issues and concerns."
The contents of the letter from the U.S. healthcare regulator the FDA will be crucial in determining whether or not Penthrox has a shot at gaining regulatory approval in the U.S.
Medical Developments International is the company behind the production and distribution of Penthrox or the 'green whistle' emergency pain medical-whistle-like-device that patients inhale as an analgesic in order to treat pain.
It's commonly carried and used by accident and emergency response teams, or other medical professionals who may need to treat sudden patient pain in athletes for example.
The 'green whistle' has been approved for use in Australia, the Middle East and more recently across most of the Western European nations, with just the Holy Grail of the lucrative U.S. healthcare market seemingly between it and unambiguous success.
It seems the champagne is on ice for Medical Developments investors, who'll hope it's not needed as an analgesic in the event of a painful rejection by the FDA.
