GREY:IPHAF - Post Discussion
Post by
professional11 on Jul 10, 2012 12:29am
LuxBio Phase 3 comments
1) Voclosporin gained fast track status for non-infectious uveitis Aug 7, 2007. https://www.biospace.com/news_story.aspx?NewsEntityId=65628
2) In order to gain fast track status, data must be convincing. https://www.glgroup.com/News/LX211-(LUX)-could-be-a-Blockbuster-Drug-in-Uveitis-Management.-16335.html
3) Fast-track drugs generally receive approval letters from the FDA in only 6-9 months after the NDA (new drug application) is submitted (see Nature Rev. Drug Disc. 8, 93, 2009).
4) If Voclosporin becomes an “FDA-approved” drug in Q4 2013, the value of ISA's Voclosporin franchise should increase significantly.
P11
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