ARTICLE | Company News
EMA picks Pluristem's PLX-PAD for adaptive pathway pilot
May 19, 2015 12:29 AM UTC
Pluristem Therapeutics Inc. (NASDAQ:PSTI) said its PLX-PAD cells to treat critical limb ischemia (CLI) were selected for EMA's adaptive pathways pilot project.
EMA's pathway is intended for programs in Phase I or Phase II that have demonstrated early signs of efficacy. Companies may seek initial marketing authorization for a restricted patient population and subsequently expand or narrow a drug's label as evidence is gathered from additional clinical trials and real-world experience (see BioCentury, June 23, 2014). ...