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Latest From Ardelyx Inc.
US FDA Adcomm Reform Ideas: Neutral Facilitator As Chair, Public Hearing Lottery Process Tweaks
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
US FDA Adcomm Reform Ideas: Neutral Facilitator As Chair, Public Hearing Lottery Process Tweaks
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
US FDA Advisory Committee Conduct Could Take Center Stage in Lykos Appeal of MDMA Rejection
Sponsor of psychedelic PTSD treatment will try rarely successful formal dispute resolution process after receiving a complete response letter.
Lykos’s Knockback Could Be An Opportunity For Rivals
The group intends to appeal the US FDA’s rejection of its MDMA-based PTSD therapy, midomafetamine, but other psychedelics could advance in the meantime.
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