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Regulatory

Nuovo Biologics and the FDA Center for Veterinary Medicine Claims Status

Much of the effort associated with discovering and bringing new drugs into the marketplace has now shifted to small and medium sized biotech companies with limited financial resources and, in some cases, has shifted to individuals. Nuovo Biologics fits this model of a small company with limited resources working to commercialize a new proprietary drug.

The Company has adopted a strategy using a dynamic, decentralized, and low-overhead approach to achieve FDA label approval for a broad spectrum anti-viral drug and a targeted anti-tumor drug for canine stages II & III oral malignant melanoma.

Our regulatory guidance approach began by applying for an FDA ADUFA (Animal Drug User Fee Act) sponsor fee waiver. To date the FDA has granted waivers for all applicable sponsor fees under the “significant barrier to innovation” provision of ADUFA totaling an estimated $800,000.

Current FDA Milestones Completed:

  • Obtained two Investigational New Animal Drug (INAD) numbers from the FDA for:
    • A broad spectrum antiviral drug for treating viral diseases in companion animals (dogs, cats, horses and birds). (INAD# 011-949)
    • The treatment of stages II and III canine oral malignant melanoma. (INAD# 013-035)
  • Obtained a Minor Use Designation (MUMS) from the FDA-CVM to treat stages II and III oral malignant melanoma in dogs. This designation allows the Company to pursue a Conditional New Animal Drug Application (CNADA), which will permit the Company to market MMX for canine oral melanoma after proving it is safe, but before collecting all the necessary effectiveness data. This designation is similar to “orphan” status for human drugs used to treat rare diseases.
  • Obtained protocol and case report form (CRF) concurrence on canine malignant melanoma study. The study will be performed at Auburn University College of Veterinary Medicine and the Veterinary Cancer Group in Southern California.
  • Obtained approval for study development plan for viral upper respiratory disease in companion animals. Developing final protocol(s) for final protocol concurrence.
  • Completed first pre-CMC (Chemistry, Manufacturing and Controls) document for FDA to review and comment. The FDA CMC approved our manufacturing process and characterization of the peptide. We are now allowed to ‘scale-up’ our process and begin our clinical trials.
  • Completed TAS (Target Animal Safety) study protocol and received FDA concurrence.

The Regulatory Path to FDA Approval
Green: Completed, Orange: Ongoing, Blue: Planned