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The Home Stretch: Pivotal Trials and Preparing for Launch

Amy Emerson, Doug Drysdale , Kabir Nath

 The psychedelic drug development field has entered a new phase, with several companies now undertaking pivotal phase 3 clinical trials, and preparing to submit data for regulatory approval to go to market. While each one has learned its own regulatory lessons from Lykos’ setback at the FDA, commercialization is uncharted territory that raises many questions. How will they build awareness to drive adoption in the medical community? How will they prepare health care providers to deliver optimal, patient-focused care? How will they make the case to insurers to pay for their medicines? And how will they use their success as a basis for building a sustainable company? Hear from senior leaders of these companies as they discuss what it has taken to reach this point, and how they are preparing for the challenges ahead.

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