Medmira Essay

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MedMira Laboratories: The U.S. OTC Decision Group 3 Date: 05 July 2013 Medmira is a leading developer and manufacturer of flow-through rapid diagnostics. The company’s tests provide hospitals, labs,clinics and individuals with reliable, rapid diagnosis for diseases such as HIV and Hepatitis C in just three minutes Medmira and US OTC Market: Medmira labs are planning to venture into OTC markets as: * There are 40,000 new cases diagnosed per year. * Approval for HIV OTC tests would open doors for common chronic tests where the market is very lucrative. * Early testing would lead to lesser chances of transmission and further infection. * Cost-effective solution. * Effective for people with need of privacy and in cases when one considers social stigma. * Useful for those people who lives in remote areas and have poor access to healthcare. Competitive advantages of Miracure: It is claimed that the product will give results faster and are quite accurate(99.8%), accessible and more confidential than the usual method of lab test which might attract more consumers. Price will be around $20-$40 which should be considerably lesser than OraSure’s products which are claimed to have more false positives. Also, OraSure had gained negative publicity through CDC’s recommendation which might influence FDA decision. In that case Medmira holds a good chance of pioneering the market as this is the first company receiving the Health Canada’s approval and also the CE Mark Approval. The OTC sales in Hongkong and China has been quite good and FDA approval gives a good chance for the market expansion. Financial implications: As the market looks convincing enough and given that Medmira wouldn’t want to lose a potential opportunity, the cost of obtaining FDA approval for OTC would be: * Filing cost: 1.5 million dollars * Packaging and

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