Posted On: 08/17/2014 7:56:10 PM
Post# of 30066
MANF RP @ U of Miami
"We have experiments underway at multiple CROs, as well as a collaboration agreement being moved forward with the University of Miami’s Bascom Eye Institute, evaluating the safety and efficacy of MANF in multiple models of Retinitis Pigmentosa. While these experiments are underway, with data expected in the next several weeks, we are concurrently putting together the necessary orphan regulatory expertise to apply for Orphan Drug Designation (ODD) with the FDA. We expect to be in a position to file for ODD with the FDA for MANF in Retinitis Pigmentosa shortly after receiving the final data sets over the summer."
MANF AIO @ U of Mass
"The Company is also continuing to move forward with other initiatives on the MANF front with Dr. Larry Schwartz at the University of Massachusetts, including the further evaluation of MANF as a treatment for the orphan indication antibiotic-induced ototoxicity, as well as other undisclosed possibilities. We believe it is absolutely critical to collaborate with leading academic groups who hold specialties in the various areas pertaining to MANF’s fundamental biology, and we expect multiple announcements on this front in the near future."
"We have experiments underway at multiple CROs, as well as a collaboration agreement being moved forward with the University of Miami’s Bascom Eye Institute, evaluating the safety and efficacy of MANF in multiple models of Retinitis Pigmentosa. While these experiments are underway, with data expected in the next several weeks, we are concurrently putting together the necessary orphan regulatory expertise to apply for Orphan Drug Designation (ODD) with the FDA. We expect to be in a position to file for ODD with the FDA for MANF in Retinitis Pigmentosa shortly after receiving the final data sets over the summer."
MANF AIO @ U of Mass
"The Company is also continuing to move forward with other initiatives on the MANF front with Dr. Larry Schwartz at the University of Massachusetts, including the further evaluation of MANF as a treatment for the orphan indication antibiotic-induced ototoxicity, as well as other undisclosed possibilities. We believe it is absolutely critical to collaborate with leading academic groups who hold specialties in the various areas pertaining to MANF’s fundamental biology, and we expect multiple announcements on this front in the near future."
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