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Yesterday, Heron Therapeutics (HRTX) unexpectedly got its second Complete Response Letter ((CRL)) from the FDA in response to its marketing application for HTX-011 to treat post-operative pain. This was a most unexpected response given the compound has both Fast Track and Breakthrough Therapy status for this indication and the industry is in desperate need of less addictive pain management options. This disappointment caused a steep sell off in the stock in trading Monday.
We revisit Heron in the paragraphs below and outline how we plan to action this recent news.