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Tuesday, October 20, 2020 11:32:43 PM
What is tropical disease?
Tropical disease, any disease that is indigenous to tropical or subtropical areas of the world or that occurs principally in those areas. Examples of tropical diseases include malaria, cholera, Chagas disease, yellow fever, and dengue
Second CTYX is in the Orphan Drug/Rare Disease space
Orphan Drug Designation Awardees are Granted the Following Benefits from the FDA:
Tax credits of 50% off the clinical drug testing cost awarded upon approval
Eligibility for market exclusivity for 7 years post approval
Waiver of new drug application (NDA)/ biologics license application
(BLA) application fee (approximately $2.2 million value)
https://www.americangene.com/blog/benefits-of-fda-orphan-drug-designation-what-you-need-to-know/
https://www.fda.gov/media/113889/download
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