Revance Therapeutics Inc (RVNC)

[DewDiligence]

Re: Double-dose Jeuveau trial

Before getting into specifics, let’s first acknowledge that there are various ways EOLS can manipulate the dataset. One variable is the proportion of moderate-wrinkle vs severe-wrinkle patients in the trial at baseline. Moderate-wrinkle patients at baseline have to improve only one point to reach none-or-mild status, while severe patients at baseline have to improve by two points to reach none-or-mild status. Hence, enrolling a high proportion of moderate-wrinkle patients will bias the duration data in a favorable direction, which is what I expect EOLS has done.

Further, EOLS can present the duration data on an ITT basis or on a “responder” basis. In the former case, patients who never respond to treatment (i.e. those who fail to ever attain a 2-point improvement) count as having a duration of zero weeks, while in the latter case such patients are excluded from the calculation of duration. Hence, it’s a pretty good bet that EOLS will present the data using a “responder” analysis.

With the above qualifiers in mind, I think EOLS will be happy to report a 16-to-18-week median duration for none-or-mild status with a ptosis rate below 5%. Inasmuch as there is no mechanistic rationale for a double dose of Jeuveau to produce data superior to the above, I’ll be suspicious of the reporting methodology if it does.