Mark please see FDA designation status for ODD so NZT is right...

Mark please see FDA designation status for ODD so NZT is right here. Orphan drug designation qualifies sponsors for incentives including:

• Tax credits for qualified clinical trials
• Exemption from user fees
• Potential seven years of market exclusivity after approval

Sponsors seeking orphan drug designation for a drug must submit a request for designation to the agency. Sponsors requesting designation of the same drug for the same rare disease or condition as a previously designated product must submit their own data and information to support their designation request. Orphan drug designation is a separate process from seeking approval or licensing.

https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products