On fluvoxamine, the FDA’s report includes additional analyses that even go beyond what I talked about regarding the NIH’s. Though I will say their discussion of the meta-analysis seemed a little disingenuous (though some comments in peer review can feel the same, so) - garbage in, garbage out is always a potential problem, and one should never hope for a meta-analysis to “substantially alter the assessment of the individual trials,” so failing to deliver on that is just par for the course and should not be viewed as a negative.
But even just taking the meta-analysis at face value, the summarized evidence of efficacy is kinda weak (a reduction in severe disease that is consistent with reductions ranging from 0-50%...consistent with 0% means “While the FDA has concluded that the existing clinical data are insufficient to support the issuance of an EUA, these data suggest that further clinical investigation may be warranted.” At least it’s not consistent with, say, −10%-40%, in which case the FDA would presumably not have thrown that bone).
On fluvoxamine, the FDA’s report includes additional analyses that even go beyond what I talked about regarding the NIH’s. Though I will say their discussion of the meta-analysis seemed a little disingenuous (though some comments in peer review can feel the same, so) - garbage in, garbage out is always a potential problem, and one should never hope for a meta-analysis to “substantially alter the assessment of the individual trials,” so failing to deliver on that is just par for the course and should not be viewed as a negative.
But even just taking the meta-analysis at face value, the summarized evidence of efficacy is kinda weak (a reduction in severe disease that is consistent with reductions ranging from 0-50%...consistent with 0% means “While the FDA has concluded that the existing clinical data are insufficient to support the issuance of an EUA, these data suggest that further clinical investigation may be warranted.” At least it’s not consistent with, say, −10%-40%, in which case the FDA would presumably not have thrown that bone).