Unmet Need Can Trump Anything At US FDA Panels, Even An Ill-Prepared Sponsor
Emmaus was unable to answer several questions about its product and was also missing several pieces of data, but FDA's Oncologic Drugs Advisory Committee didn't criticize the sponsor, and instead praised it for paying attention to the largely neglected sickle cell disease.
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Epidiolex May Have Avoided CRL Over Metabolite Assessment Due To Unmet Need
Lead pharmacology/toxicology reviewer said Epdiolex was not approvable because of inadequate assessment of 7-COOH-CBD human metabolite, but supervisor said it could be conducted in postmarketing phase because of the unmet need the drug fills.
Emmaus Plans Modest Pricing In 4Q Rollout Of Sickle Cell Drug Endari
With an eye on a patient population mainly covered by Medicare and Medicaid, Emmaus Life Sciences CEO Yutaka Niihara says the company wants to ensure its pharmaceutical grade L-glutamine product is accessible in the US.
Puma Breaks A Long Losing Streak For Sponsors At ODAC
Puma is in select company after winning a strong vote from US FDA’s Oncologic Drugs Advisory Committee in favor of approval of its new cancer drug neratinib.