- STADA Arzneimittel AG to cut 800 jobs...
- J&J Fails to win FDA OK for daily HIV pill...
- FDA warns J&J over vaginal products...
- Alnylam Pharmaceuticals lung drug fails mid-stage trial...
- Flexion Therapeutics reports positive data for osteoarthritis drug...
- Bristol Myers Squibb Company drug seen helping attack lung cancer...
Early stage - positive results: "These results represent a significant advance..." "This could be a breakthrough..." "It's a turning point..." Actual quotes from these stories
Phase IIb - mitigated failure: "The study missed the primary endpoint... We believe that these data provide important evidence..."
FDA review - failure: "The company said it is reviewing the FDA's response to its marketing application and it plans to respond as quickly as possible."
FDA Warning - "The regulator said it could not determine the adequacy of the company’s responses until J&J completed an investigation of each one and provided them to the FDA."
Notice how the people cheerleading the narrative start to fade away as a drug moves further down the line in development. The narrative starts to show signs of fallibility and the story tellers walk away. They are the positive ones. They are the ones who say things like "significant advance" and "turning point". They are not the ones who say, "missed the primary endpoint" or "failed". In the end the leaders slip behind the curtain of Oz and let the Wizard speak. We are left with that empty feeling when something happens, good or bad, and we don't know why.
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