(Total Views: 326)
Posted On: 11/22/2019 12:40:49 PM
Post# of 154726
I'd really like to read the protocols of the FDA meetings at some point.
Sometimes I am wondering whether a bit more persistance would have produced a different outcome: would the FDA seriously have denied a path for approval with over 80% efficacy with 350mg in an unmet medical need population, if CYDY had insisted on submitting an application for 350mg only at that time with a plan to collect more data post-approval, e.g. collecting safety data fo 525 and 700mg to support future sBLAs could via a pivotal mono trial)? (If they immediately said yes and amen to everything the FDA proposed that would be something else).
Sometimes I am wondering whether a bit more persistance would have produced a different outcome: would the FDA seriously have denied a path for approval with over 80% efficacy with 350mg in an unmet medical need population, if CYDY had insisted on submitting an application for 350mg only at that time with a plan to collect more data post-approval, e.g. collecting safety data fo 525 and 700mg to support future sBLAs could via a pivotal mono trial)? (If they immediately said yes and amen to everything the FDA proposed that would be something else).
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