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  "documentTitle": "Bristol-Myers Squibb Company (BMY)",
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  "notes": "Uses a before-after framing to contrast management's pre-RTF optimism with post-RTF deflection.",
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      "kind": "callout",
      "text": "Celgene was hyper focused on the ozanimod launch but didn't care enough to double-check that the FDA filing was adequate?",
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      "text": "Management Commentary Leading Up to the RTF vs Management Commentary Post-RTF",
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      "text": "In February 2018, Celgene announced that the company had received an RTF letter from the FDA because the non-clinical and clinical pharmacology sections were insufficient to permit a complete review.\nBased on conversations with industry experts, we believe ozanimod may have had certain issues with its safety profile.",
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      "text": "Ozanimod received a refusal-to-file (“RTF”) from the FDA despite continuous bullish commentary, heavily damaging the credibility of Celgene’s management team.",
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      "text": "\"Turning to ozanimod. We are highly encouraged by the results we've seen to date in both SUNBEAM and RADIANCE pivotal trials for RMS. We remain focused on preparing for a world-class launch in the RMS market...and we remain on track for launch readiness by Q4 this year.\" — Terrie Curran, President – Inflammation & Immunology, January 2018. \"I think that 99% of folks at Celgene wouldn’t have submitted, but we had Receptos out on the West Coast and, for whatever reason, the decision was made to submit. We learned a lesson of humility and that when you do an acquisition it’s better to be more integrated rather than be completely away from the mothership.\" — Nadim Ahmed, President – Hematology & Oncology, June 2018 – Speaking to Financial Times.",
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      "text": "Source: Public company filings, press releases, industry research and interviews.",
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      "text": "An RTF for Celgene's next potential blockbuster drug was followed by finger pointing and attempts to avoid responsibility, yet Celgene still wants shareholders to trust that ozanimod has bullish prospects",
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      "text": "Despite Consistent Bullish Commentary From Celgene Management, Ozanimod Already Received an RTF",
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