In an opinion article, The Wall Street Journal’s The Editorial Board argued that the Food and Drug Administration’s rejection of Replimune’s (REPL) RP1 melanoma therapy contradicts both expert opinion and the agency’s own initial review panel, which had recommended approval. According to the piece, FDA leadership replaced that panel with reviewers who still did not conclude the drug was ineffective, yet the agency denied approval based on what the article describes as flawed reasoning about trial design. Multiple melanoma specialists quoted in the article say RP1 has produced remissions in patients who had exhausted all other options, and they view the rejection as medically unsound and harmful to patients. Shares of Replimune have gained over 21%, trading at $2.26.
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