PharmaCom BioVet, Inc. (PINKSHEETS: PHMB) is pleased to announce that the Company has begun the process to potentially apply and endeavor to receive a Minor Use/Minor Species (MUMS) drug approval from the Federal Drug Administration (FDA). Meeting the MUMS requirement is part of the New Drug Approval Process if the Company decides to potentially run clinical trials on a histone deacetylase inhibitor for canines with hemangiosarcoma, which the Corporation is considering the development of. The histone deacetylase inhibitor would be directed for dogs suffering from an acute type of cancer, canine hemangiosarcoma. The Minor Use and Minor Species Animal Health Act became law in 2004.

Minor uses are based on there being a small number of animals eligible for treatment with the product in question for the specific intended use. Small numbers have been determined for each of the 7 major species (cows, horses, pigs, chickens, turkeys, dogs, and cats). These have been published in a proposed rule (http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-5385.pdf). To determine if a use is minor, the standard is that the intended use is for a "small number of animals." There is a different "small number" for each of the 7 major species and it reflects the number of animals affected by the disease over a one-year period.

"We are continuing to review the FDA filing requirements in order to determine if we may meet the requirements stated by the MUMS Act. By doing so, we potentially progress closer to being able to begin the testing of a novel cancer treatment for canines with Hemangiosarcoma," stated Gary S. Berthold, President of PharmaCom BioVet, Inc.

About PharmaCom BioVet, Inc.:

PharmaCom BioVet, Inc. is positioning itself to become involved in the specialized Veterinary oncology development and treatment industry. PHMB is pursuing the licensing and the development of proprietary compounds and devices.

Safe Harbor Statement:

The information posted in this release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimate," "project," "intend," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technological advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, and various other factors beyond the Company's control.

Contact: PharmaCom BioVet, Inc. Investor Relations Tel: (407) 389-5900 URL: http://www.PharmaComBioVet.com

PharmaCom BioVet (CE) (USOTC:PHMB)
Historical Stock Chart
From Oct 2024 to Nov 2024 Click Here for more PharmaCom BioVet (CE) Charts.
PharmaCom BioVet (CE) (USOTC:PHMB)
Historical Stock Chart
From Nov 2023 to Nov 2024 Click Here for more PharmaCom BioVet (CE) Charts.