Posted On: 01/12/2016 3:40:58 PM
Post# of 72446
Repost from over yonder
So much for Rosen's proper Due Diligence.
" Brilacidin will not be eligible to receive a “qualified infectious disease product” designation that would allow a fast-track approval process as an antibiotic .2"
http://ia601507.us.archive.org/4/items/gov.us...4.32.0.pdf
BEVERLY, MA–(Marketwired – November 25, 2015) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Brilacidin-OM, an oral rinse formulation of the Company’s novel defensin-mimetic Brilacidin, for the prevention of oral mucositis. - See more at: http://cellceutix.com/fda-grants-fast-track-d...OsLii.dpuf
.... is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation for Brilacidin as a new treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI ) ahead of its meeting this month with Cellceutix regarding Cellceutix’s planned Phase 3 trial of Brilacidin for ABSSSI. - See more at: http://cellceutix.com/cellceutix-antibiotic-b...yExyJ.dpuf
So much for Rosen's proper Due Diligence.
" Brilacidin will not be eligible to receive a “qualified infectious disease product” designation that would allow a fast-track approval process as an antibiotic .2"
http://ia601507.us.archive.org/4/items/gov.us...4.32.0.pdf
BEVERLY, MA–(Marketwired – November 25, 2015) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Brilacidin-OM, an oral rinse formulation of the Company’s novel defensin-mimetic Brilacidin, for the prevention of oral mucositis. - See more at: http://cellceutix.com/fda-grants-fast-track-d...OsLii.dpuf
.... is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation for Brilacidin as a new treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI ) ahead of its meeting this month with Cellceutix regarding Cellceutix’s planned Phase 3 trial of Brilacidin for ABSSSI. - See more at: http://cellceutix.com/cellceutix-antibiotic-b...yExyJ.dpuf
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