Proactive Investors - Run By Investors For Investors

CannPal Animal Therapeutics’ sponsor fee for lead animal drug candidate waived by US FDA

CannPal plans to take the results from its recently commenced phase 1A and B studies to file an Investigational New Animal Drug application with the FDA.
A dog and a cat
The phase 1B study is now well underway

CannPal Animal Therapeutics Ltd (ASX:CP1) has been granted its second US FDA (Food and Drug Administration) sponsor fee waiver for its lead drug candidate CPAT-01.

CPAT-01 is an innovative cannabis-derived pain control for cats and dogs.

The waiver was granted under the significant barrier to innovation provision of the FDA’s Animal Drug User Fee Act (ADUFA) of 2003.

The waiver covers the current US$75,150 FY18 ADUFA sponsor fee which can be renewed each US fiscal year.

CannPal may also be eligible for reductions in other fees such as the drug application fee which can cost in excess of US$300,000.

READ: CannPal Animal Therapeutics commences dog pain control study

The company was initially granted a fee waiver for an osteosarcoma pain treatment under the Minor Use/Minor Species (MUMS) pathway in 2017 which is a pathway that applies to diseases that affect a minor number of patients every year.

This new waiver under the barrier to innovation pathway is applicable to much broader indications, which allows CannPal to apply the waiver to CPAT-01D, which is being developed as a pain control in dogs.

CannPal plans to take the results from the recently commenced phase 1A and B studies to file an INAD (Investigational New Animal Drug) application with the FDA prior to the AU FY19 financial year, at which point the sponsor fee would be required to be paid.

READ:  CannPal Animal Therapeutics positioned in a growing animal health market

CannPal founder and managing director Layton Mills said: “Receiving this fee waiver not only provides additional cost savings for the company but also further validates our focus on following regulatory protocol and seeking added value opportunities for our shareholders.

“The phase 1B study is now well underway and we are looking forward to continuing on our path of developing safe and scientifically-proven treatments for companion animals.”

Join Proactive’s Crypto, Blockchain and Cannabis Telegram group here
View full CP1 profile View Profile

CannPal Animal Therapeutics Ltd Timeline

Related Articles

muffins and cannabis
November 30 2018
Dehydratech is essentially a delivery system that allows drugs and vitamins to get into the bloodstream quicker, while making them taste and smell better at the same time
cannabis on dollar bills
June 09 2019
Australis invests in the highly fragmented, rapidly evolving US cannabis space, with a focus on building companies through early-stage, diversified and opportunistic investments
Cannabis leaf
November 19 2018
With the legalisation of recreational cannabis in Canada in October, and the US expected to follow suit, the company has its sights set on building up the very best in the industry

© Proactive Investors 2019

Proactive Investors Australia PTY LTD ACN:132787654 ABN:19132787654.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use