September 27, 2021
Mesa Green Pharma LLC. Receives Positive Feedback from FDA’s Center for Veterinary Medicine
FREDERICK, Md. September 21,2021— Mr. Michael Mesa, CEO of Mesa Green Pharma (MGP) stated that “company representatives met with FDA’s Center for Veterinary Medicine (CVM) on September 9, 2021, to discuss the company’s development program for K9MGP.” MGP is developing K9MGP as a treatment to stop active generalized seizures in canines that can be administered at home by the pet-owner. Mr. Mesa also advised that “once approved, K9MGP will be the only FDA approved product to treat active generalized seizures in canines. K9MGP will fill a significant unmet need in canine health care by providing treatment as soon as possible after a seizure begins to minimize canine brain damage and improve quality of life for the pet and its owner alike.”
At the meeting MGP introduced data from pilot studies completed at the University of Minnesota in conjunction with the Mayo Clinic that demonstrated when administered in an intramuscular injection via a prototype auto-injector system, K9MGP reaches the dog brain rapidly, and quickly achieves a therapeutic blood level. MGP believes the pilot study supports the continued development of the innovative approach to solving the seizure treatment unmet need. These data will be presented at the December 2021 American Epilepsy Society Meeting.
Discussions with CVM during this meeting provide confidence for MGP’s plans to open an Investigational New Animal Drug (INAD) file in 1Q2022. Once the INAD is open, MGP will discuss details regarding the Target Animal Safety Study and the Effectiveness Study with CVM before submitting a request for Expanded Conditional Approval.
Mesa Green Pharmaceutical Company, a subsidiary of Mesa Science Associates Inc, is a veteran owned business with offices inside the Frederick Innovation Technology Center (FITCI), which is in Frederick MD. Inquiries regarding investment opportunities should be directed to Michael Mesa at [email protected].