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Thursday, September 21, 2023

Immix: 2nd Orphan Status for Candidate

 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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