MVP big break to get Pentrox approved in USA has just got a shot in the arm as the US FDA is willing to give consideration -this would be the catalyst to make this an ASX200 stock - this could solve the opiod problem in the US?
Penthrox® USA Update
Medical Developments International Limited (ASX: MVP) advises that it met with the Food and Drug Administration (FDA) in mid-June 2019 in respect to its IND clinical hold letter issued in August 2018.
MVP now expects to be in a position to address in full, all the clinical hold issues during the first quarter of 2020.
MVP CEO, Mr. John Sharman said: “We had a good discussion with the FDA and we are clear as to what is required. Of particular importance is the willingness of the FDA to consider the recent safety data generated in Europe, and in particular the United Kingdom’s Post Authorisation Safety Study. We are confident this data will prove the safety of Penthrox® to the satisfaction of the FDA and expect to submit our full response to the IND clinical hold during early 2020.”
MVP can advise that as a result of the recent meeting with the FDA:
The FDA has agreed that a requested animal study to predict idiosyncratic liver reaction to Penthrox® would not be required to be performed.
MVP has agreed to conduct a required animal study that replicates the human dosing regimen for Penthrox®. MVP expects the study to take 6 months to complete.
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