The Orphan Drug Designation today covers all TCLs and their subtypes.-“Prescient is delighted to be granted this Orphan Drug Designation by the FDA, and is pleasantly surprised for the granting of the designation that is broader than our request,” commented Prescient CEO, Steven Yatomi-Clarke“This now confers the certainty of 7 years of market exclusivity for PTX-100 in a broader range of diseases with unmet or poorly met clinical need.”
Market exclusivity 7 years from fda approval. They also have a patent (exp ‘31) on a bio marker that indicates which patients would benefit from PTX-100 in breast cancer.
The granting of FTD combined with the orphan drug designation and comments by the Trump administration on new drug programs have significantly de-risked Ptx-100, for me. I think they have a very strong chance of being classified as a breakthrough drug ( which they are aiming for).
This a buy for me. I’ve doubled down here. This one will reward long term,imo and when the re-rate comes it will be quick.
Ann: PTX-100 receives U.S. FDA Fast Track Designation, page-58
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