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Friday, January 12, 2018 9:18:43 AM
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-receives-rare-pediatric-disease-designation-from-fda-for-kevetrin-for-the-treatment-of-retinoblastoma?rq=priority%
“Receiving the Rare Pediatric Disease designation strengthens our portfolio and adds to our belief that Kevetrin has the potential to provide a meaningful therapeutic benefit to children and families affected by retinoblastoma, where enucleation (removal) of the eye is often the only solution,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “We are putting plans in place to move ahead with this exciting project. We view the voucher program as very valuable in meeting areas of unmet medical need and certainly keep in mind the monetary component considering United Therapeutics recently agreed to sell its Rare Pediatric Disease Priority Review Voucher to a subsidiary of AbbVie for $350 million.”
http://www.ipharminc.com/press-release/2016/11/16/fda-grants-fast-track-designation-to-cellceutixs-brilacidin-om-for-oral-mucositis?rq=priority%20review
The FDA established the Fast Track Designation process to facilitate the development, and expedite the review of, drugs that have the potential to treat serious and life threatening conditions and fill an unmet medical need. Drugs developed under the Fast Track program are afforded increased access to the FDA and could qualify for other programs to expedite development, including priority review and accelerated approval.
Kelt
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