CannPal to file with FDA after positive and "surprising" results for cannabis pet medicine
By administrator | 14 December 2018
Having the data now to actually move forward and file an INAD is definitely what we're excited about," says CannPal Animal Therapeutics (ASX: CP1) founder and managing director Layton Mills.
An INAD (Investigational New Animal Drug) application in the US may not sound exciting to most, but in pharmaceutical development it signifies a leap seldom seen in cannabinoid drugs for animals or humans.
With the latest results from a dosing study of CannPal's cannabis-based drugs for dogs, founder Layton Mills says the company is ready to take this big step with the US Food and Drug Administration (FDA) in early 2019.
"It's not actually filing for approval of the drug, but it's the first time you have enough data to sit down with the FDA," he tells Business News Australia.
He says the process is very collaborative, and CannPal will be showing the positive results of its tests with cannabinoid impacts on genetic markers, while demonstrating the safety profile of the pain and inflammation drug (CPAT-01) while sharing development plans for the coming 18 months.
The FDA is expected to take these results and plans into account before subsequently making its own recommendations. Read more
Matt Ogg - Business News Australia - 12 November 2018
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