Gotinearly,
Here is some information from the FDA.GOV website about the animal drug approval process. Not sure where the company is at this time but they have been testing NR2F6 for some time. The patent may validate animal test results already and a foreseen market.
Hope this helps.
A Brief Summary of the Drug Approval Process(Animal Drugs).
A drug sponsor is the entity responsible for collecting all the information about a new animal drug and submitting this information to CVM for review.
Who can be a drug sponsor? Any organization, or even one person, can be a drug sponsor. For example, scientific research groups; government agencies, such as the U.S. Department of Agriculture; and academic organizations, such as colleges and universities, can all be drug sponsors. But typically, drug sponsors are pharmaceutical companies.
•The drug sponsor collects information about the safety and effectiveness of a new animal drug. The sponsor may need to conduct studies to get this information. For any studies that are performed, the sponsor analyzes the results.
•Based on the collected information, including any study results, the sponsor decides if there is enough proof that the drug is safe and effective to meet the requirements for approval.
•The sponsor submits a New Animal Drug Application (NADA) to CVM. The NADA includes all the information about the drug and the proposed label.
•A team of CVM personnel, including veterinarians, animal scientists, biostatisticians, chemists, microbiologists, pharmacologists, and toxicologists, reviews the NADA. If the center's team agrees with the sponsor’s conclusion that the drug is safe and effective if it is used according to the proposed label, the NADA is approved and the drug sponsor can legally sell the drug.
Misconception: The drug approval process starts with CVM.
Truth: The drug approval process starts with the drug sponsor. The sponsor conducts initial research on a potential new animal drug, and if the research is promising, the sponsor contacts CVM to start discussions about the drug and the approval process.
Misconception: CVM tells the drug sponsor which new animal drugs to research and develop.
Truth: The drug sponsor decides which new animal drugs to research and develop for possible approval. CVM and the sponsor discuss what information is needed to get a drug approved.
Misconception: CVM tests a new animal drug for safety and effectiveness.
Truth: The drug sponsor is responsible for testing a new animal drug for safety and effectiveness. CVM reviews the results of the testing to decide if the drug is safe and effective to meet the approval requirements.
