WideTrial seeks to increase expanded access programs by helping companies recover costs

FDA has authorized WideTrial Inc. (San Francisco, Calif.) to charge payment for an expanded access program for critical limb ischemia (CLI) candidate PLX-PAD from Pluristem Therapeutics Inc. (NASDAQ:PSTI; Tel Aviv:PSTI) under a cost recovery program. The program will initially enroll 100 patients with life-threatening CLI who are ineligible to enroll in Pluristem's clinical trials.

“Traditionally, clinical stage drug companies haven’t been well rewarded for serving the treatment needs of patients outside of research trials," WideTrial founder and CEO Jess Rabourn told BioCentury. "In fact, there are more perceived downsides than upsides."...