Posted On: 10/28/2014 9:54:05 AM
Post# of 30066
Looking for analysis. I'm still a little unclear on the Orphan process. This is new on the FDA site. Good, bad? I'm unclear.
http://www.accessdata.fda.gov/scripts/opdlist...ber=447714
Generic Name:Non-replicating recombinant adeno-associated virus vector containing a fragment of the gene encoding channelrhodopsin-2 protein
Trade Name: n/a
Date Designated: 10-20-2014
Orphan Designation: Treatment of retinitis pigmentosa
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sponsor: RetroSense Therapeutics, LLC
330 East Liberty Street, LL
Ann Arbor, MI 48104
http://www.accessdata.fda.gov/scripts/opdlist...ber=447714
Generic Name:Non-replicating recombinant adeno-associated virus vector containing a fragment of the gene encoding channelrhodopsin-2 protein
Trade Name: n/a
Date Designated: 10-20-2014
Orphan Designation: Treatment of retinitis pigmentosa
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sponsor: RetroSense Therapeutics, LLC
330 East Liberty Street, LL
Ann Arbor, MI 48104
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