I see that there are many new callers on the line today, so let me start by providing you with a little perspective on how we developed Prochymal.We were 20 years ago with a mission to responsibly develop and commercialize the stem cell-based therapy to address significant unmet medical needs. In 1992, we began performing the necessary laboratory work to enter human trials with mesenchymal stem cells. After 6 years of bench work, we initiated our first Phase I human clinical trial with MSCs in 1998. Since that time, Osiris has achieved many firsts in the field of stem cells including the first stem cell product to be awarded Fast Track status by the FDA; the first stem cell drug to be granted orphan drug status by FDA and EMA; the first Expanded Access Program to be approved for a stem cell drug, enabling patients all over the world to receive treatment with Prochymal; and finally, with Prochymal becoming the world's first approved stem cell drug and the first drug specifically approved for the management of acute GvHD.
Osiris Therapeutics Management Discusses Q2 2012 Results - Earnings Call Transcript
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