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Posted On: 11/05/2024 12:06:38 AM
Post# of 148863
Surrogate reads like anecdotal is back in play.
" The FDA can grant accelerated approval based on a surrogate endpoint, which is something that is thought to predict clinical benefit. This allows for earlier access to drugs while confirmatory studies are still
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If protocol includes Interim, with Dr. J, Syneos & Max, I would expect a fair Safety Board recommendation.
Of course we'd still need FDA to accept a SB recommendation of anything related to an Accelerated Approval.
Dr. J's FDA relationship comments sure ringing bells now.
" The FDA can grant accelerated approval based on a surrogate endpoint, which is something that is thought to predict clinical benefit. This allows for earlier access to drugs while confirmatory studies are still
___
If protocol includes Interim, with Dr. J, Syneos & Max, I would expect a fair Safety Board recommendation.
Of course we'd still need FDA to accept a SB recommendation of anything related to an Accelerated Approval.
Dr. J's FDA relationship comments sure ringing bells now.
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