25 July 2018
Medical Developments International (ASX: MVP) today advised that it met with the Food and Drug Administration (FDA) for the United States of America overnight. The FDA has advised 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. That letter is expected within two months.
MVP CEO Mr. John Sharman said: “This setback in our timetable to have Penthrox approved for sale in the US is very disappointing. We must now wait and see what the FDA require us to do, in addition to the work we have already done.”
We will report to the market as soon as we have further information.
Please refer attached for the full announcement – ASX Announcement – USA Update