Trevena forges plan to take once-rejected opioid across finish line, after 'productive' FDA meeting
Tiny Trevena may have a new lease on life for its controversial opioid painkiller — rejected by the FDA last November citing the dearth of drug safety data — following a scathing internal staff critique and lopsided expert panel review.
The company’s shares $TRVN swelled nearly 120% on Monday after Trevena said the agency had agreed that the drug’s existing safety database would suffice for a particular dose of the drug — helping forge a path forward for the biotech to resubmit its marketing application.
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