Hello Mr. Alfonso:

          This is Orlando Alvarez-Fuentes.  I am reaching to you this time as Vice-President and partner of a new company, rooted in Florida, and called G&G Petcurae and I am respectfully asking for 10 to 15 minutes of your time to evaluate a summary of a business plan designed to put on the market a new veterinary drug product that will effectively treat and cure digital dermatitis on dogs, cats, poultry, cattle, sheep, and horses.

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          This novel veterinary drug, could potentially cure digital dermatitis in a time no longer than 3 weeks, save several visits to the veterinary, avoid painful and ineffective treatments like surgery, minimize the weakness of the animal’s immune system through antibiotic’s cocktails, minimize economic losses, and have a positive impact in extending the life and quality of life of pets around the World. We are either looking for a loan or, more likely, a business partner, to whom we are willing to transfer 10% of G&G Petcurae plus a 30% ROI on total initial investment.

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          Digital dermatitis has as many meanings as species it occurs at; for instance, it is known as Interdigital Cyst Syndrome, Pododermatitis, and Interdigital Furunculosis in dogs, Plasma Cell Pododermatitis in cats and other felines, called Subcutaneous Pododermatitis, “Bumblefoot” or “Footpad dermatitis” in poultry, “Foot Rot” in sheep, “Lameness” in cattle, and in horses and other equids can be known as “Scratches”, “Dew Poisoning”, “Grease”, Equine Pastern Dermatitis, or Pastern Folliculitis.

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          Independently of the name for which this disease is known, the reality is that digital dermatitis is the gateway to a myriad of dermatological infections on the affected animals and its incidence is at a 1:4 ratio on global population of individuals. Another reality is that this disease has an enormous negative impact in the economy worldwide. Lameness, for example, not only causes significant economic losses, but it has an impact on the health of the animals that suffer from it (Ózsvári, 2017; Palmer and O’Connell, 2015; Yang et al., 2020). Only in England, lameness in sheep represent a financial loss of about £ 28 million per year, whereas in dairy cows, is about 190 million of dollars per year (Enting et al., 1997; Ózsvári, 2017). In poultry, broilers to be more specific, the estimated loss is from 80 to 120 million of dollars per year (Aydin, 2018). Animals suffering from lameness not only will show signs of extreme discomfort but also, because the animals tend to spend more time lying on the floor, it is responsible for changes in behavior, stress, and for developing a negative energy balance (NEB) state that leads to a Pleiades of more severe secondary diseases (Ózsvári, 2017). 

NOTE: The data presented here and derived from tangible economic losses, is from studies on First World Countries only; however, the data derived from emotional damages, due to the loss of a companion pet, has not being quantified!

          It is apparent that the inefficiency of various treatments obeys to the quick adaptation of the microorganisms by becoming resistant to any battery of antibiotics that have been used against them. Our new product has apparently overcome such difficulties by exposing the lesion, via one of its ingredients, to proper treatment.

          Since October 1, 2019, we have been in contact with the Center for Veterinary Medicine (CVM) at the FDA to obtain information about how to effectively evaluate and later commercialize this new product that we have called AsuROCKTM. As mentioned before, AsuROCKTM was invented to treat Interdigital Furunculosis in dogs, for which no cure is currently on the market. The product and labeling material conform with existing monographs for all ingredients used in the formula.

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          We have received positive responses from the FDA and CVM compliance officers which had guided us towards the steps needed to be completed to make this drug legal and ready for marketing and distribution in the US. It would be mandatory for us to:

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1. collect first substantial scientific evidence about the effectiveness and safety of AsuROCKTM on the different animal species for which we may have a health claim;

2. complete a clinical study in at least one (1) species; and

3. submit all evidence, data, and scientific reports to the CVM at FDA to apply for a NADA (New Animal Drug Application).

          We have a great interest in putting AsuROCKTM on the market to provide a cure, that is nonexistent nowadays, to this painful disease that develops in areas with a high number of sensory nerves.

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          To achieve this initial goal, we will need to, first and foremost, address steps 1 to 3. Investing in the pharmaceutical industry, especially when trying to put a new drug on the market, is not inexpensive, however, this kind of projects provides a highly appealing Return of Investment (ROI). Moreover, G&G Petcurae is the owner of the patent to this product and will preserve exclusivity for manufacturing, selling, and distribution for the next 18 years.

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          Table 1 illustrates projected revenue, initial investment, net profit, and ROI for the product. It is included in the analysis two proposed forms of packaging for the finished product with two brackets for selling prices. It is also included the analysis of two phases for the development of the business; Phase I includes the initial investment, which is excluded from Phase II. Expenses related to insurance, advertising, and marketing campaign are not included here; however, logistics and storage of finished products is somewhat included. To maximize ROI, the manufacturing batches are for 10,000 units each; this plan optimizes reduction of expenses while, at the same time, guarantees full compliance with Federal regulations regarding good manufacturing practices (GMP).