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Novera is planning to seek an orphan drug designation from the FDA for two separate indications-one for chronic wounds and one for acute wounds. While it is common for Orphan Drugs to realize annual sales in excess of $200 million, the "Orphan Drug" designation has a number of federal benefits associated with it, as well, such as:
- Accelerated review of data by FDA, which alone could save more than a year in commercial development time.
- Tax credits for 50 percent of all costs associated with human trials, making it much easier to secure sponsorship from area hospitals and clinics.
- Grant dollars of up $200,000 per year for human trials.
- Seven years of market exclusivity granted by FDA, regardless of the life of the intellectual property.
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