Biotech Values

[biotech jim]

FDA’s statistics reviewer is critical of dataset’s inability to quantify efficacy difference between low and high doses

Now that is silly, and I am being kind here. Perhaps the reviewer meant that for the Ph3 studies in some cases REGN/SNY pooled the 75mg and 150mg dose groups. I am sure they will break that out for the review. Further, as can be seen in the Ph2 dose-response (DR) study, there is a clear and convincing DR. I refer to 3 data sets below that address this silly concern by the reviewer. Please argue about a lack of DR with this data set, and there will be more Ph3 data discussed at the review.

Since I do not know how to paste a fig here, anyone interested needs to see Table 2 and Figs 6 and 7 in the REGN/SNY briefing document. Is there an instruction set here on IHub as to how to paste figures?

Table 2 shows a 75mg vs 150 stat sig difference in LDL-C in the pooled Ph3 studies. Fig 6 shows the Ph2 dose ranging studies from 50mg to 100mg to 150mg to 200mg to 300mg on LDL-C lowering. Nice DR seen, and no further response over at doses >150mg. Fig 7 shows a beautiful DR over 12 weeks in LDL-C lowering ocwer a 12 week period with biweekly assessments (study DFI11565).

Do you think the reviewer is scratching his/her head as to why REGN is up over 20 bucks today?