some of their cases are wild. Example: https://www.ktmc.com/featured-case/celgene-corp-inc
Dayummm.
ETA: I really respect current CYDY's approach to managing expectations appropriately; slow burn better than us getting burned.
Quote:Celgene told investors that it would file a New Drug Application (“NDA”) for Ozanimod with the FDA in 2017. Unbeknownst to investors, however, Celgene discovered a metabolite named CC112273 (the “Metabolite”) through Phase I testing that Celgene started in October 2016, which triggered the need for extensive testing that was required before the FDA would approve the drug. Despite the need for this additional Metabolite testing that would extend beyond 2017, Defendants continued to represent that Celgene was on track to submit the NDA before the end of 2017 and concealed all information about the Metabolite. In December 2017, without obtaining the required Metabolite study results, Celgene submitted the Ozanimod NDA to the FDA. Two months later, the FDA rejected the NDA by issuing a rare “refuse to file,” indicating that the FDA “identifie[d] clear and obvious deficiencies” in the NDA. When the relevant truth was revealed concerning Ozanimod, Celgene’s stock price fell precipitously, damaging investors
Dayummm.
ETA: I really respect current CYDY's approach to managing expectations appropriately; slow burn better than us getting burned.
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