(Total Views: 738)
Posted On: 08/22/2020 1:10:13 PM
Post# of 154012
UK Accelerated Approval guidelines
There seems to be some uncertainty about the timeline, and it's not surprising. Maybe someone can unconfuse me.
The MHRA tells us that COVID19 "studies" are assessed to determine if they "will be accepted for fast-track review if they fall into one of the following categories." The first category is "a study of a vaccine, treatment, or diagnostic for Covid19."
So clearly Leron falls into that category, which means the study will be "reviewed within 36-72 hours of submission."
But wait. Is REVIEWING THE STUDY the same thing as approving the drug for EUA? They say studies will be reviewed by "Approvals Specialists." Yet I'm not sure if the 36-72 hour timeline is applicable to CYDY's request for Fast Track Approval. Does anyone know for sure? TIA.
There seems to be some uncertainty about the timeline, and it's not surprising. Maybe someone can unconfuse me.
The MHRA tells us that COVID19 "studies" are assessed to determine if they "will be accepted for fast-track review if they fall into one of the following categories." The first category is "a study of a vaccine, treatment, or diagnostic for Covid19."
So clearly Leron falls into that category, which means the study will be "reviewed within 36-72 hours of submission."
But wait. Is REVIEWING THE STUDY the same thing as approving the drug for EUA? They say studies will be reviewed by "Approvals Specialists." Yet I'm not sure if the 36-72 hour timeline is applicable to CYDY's request for Fast Track Approval. Does anyone know for sure? TIA.
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