FDA Orphan Drug Designation (“ODD”) qualifies one-time treatment NXC-201 for:
7 years of U.S. market exclusivity after approval
Tax credits for qualified clinical testing
Waiver of the Prescription Drug User Fee (currently at almost $3 million for a new drug)
The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research
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