By Ted Chen / Staff reporterDrug developer PharmaEssentia Corp (藥華醫藥) on Wednesday said that a meeting with US Food and Drug Administration (FDA) officials over the Lunar New Year holiday has brightened the outlook for its new blood cancer drug. PharmaEssentia is aiming to submit a biologics license application this year and gain marketing approval by 2020, according to the Taipei-based company, which specializes in hematology. The company took many months to assemble a delegation of key opinion leaders, former FDA officials and contract research organization representatives to attend the meeting with the regulator, it said. Official meeting minutes by the FDA are expected in the next 30 days, the company said, adding that it would update the investing public with the relevant information. Shares in PharmaEssentia yesterday gained 0.3 percent to NT$168.5, down from a recent high of NT$173 on Feb. 9.
Source: Taipei Times February 22, 2018 15:56 UTC