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Re: MarkDaShark post# 28347

Tuesday, 10/20/2020 11:32:43 PM

Tuesday, October 20, 2020 11:32:43 PM

Post# of 44347
First that link is intended for Tropical Diseases

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