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Posted On: 04/17/2018 1:21:59 PM
Post# of 177
$UBQU (Related - Copy from another board) HOLY SHIZNITZ FDA IS GOING TO approve CBD THIS WEEK !!!! UBQU to the MOON
This is the FDA Briefing Document for Thursday's Advisory Committee meeting:
https://www.fda.gov/downloads/AdvisoryCommitt...604736.pdf
“Conclusions
Clinically meaningful and statistically significant reductions in seizure frequency were demonstrated in three adequate and well-controlled trials in LGS and DS.
The results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with LGS and DS.
In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders.
Although the risk of liver injury has the potential to be serious, the observed risk can be appropriately managed with inclusion of relevant language in labeling, education of prescribers regarding the risk of transaminase elevation and need for monitoring of liver enzyme levels, and further characterization of the risk in the post-market setting.
Although the review is still ongoing, the risk-benefit profile established by the data in the application appears to support approval of cannabidiol for the treatment of seizures associated with LGS and DS.”
This is the FDA Briefing Document for Thursday's Advisory Committee meeting:
https://www.fda.gov/downloads/AdvisoryCommitt...604736.pdf
“Conclusions
Clinically meaningful and statistically significant reductions in seizure frequency were demonstrated in three adequate and well-controlled trials in LGS and DS.
The results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with LGS and DS.
In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders.
Although the risk of liver injury has the potential to be serious, the observed risk can be appropriately managed with inclusion of relevant language in labeling, education of prescribers regarding the risk of transaminase elevation and need for monitoring of liver enzyme levels, and further characterization of the risk in the post-market setting.
Although the review is still ongoing, the risk-benefit profile established by the data in the application appears to support approval of cannabidiol for the treatment of seizures associated with LGS and DS.”
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