Revance Therapeutics Inc (RVNC)

[DewDiligence]

Re: Median duration of SAKURA-1/2 none-or-mild status

The Kaplan-Meier curves shown in Fig. 4 of https://pubmed.ncbi.nlm.nih.gov/31609882/ are based on the duration during which either the patient’s self-assessment or the investigator’s assessment was none or mild. In other words, for this set of K-M curves, the curves moved rightward without stepping down at a given time point for a given patient only if both the patient and the investigator assessed the patient as no longer having none-or-mild status.

Conversely, the K-M curves in Fig. 2 and Fig. 3 of the pubmed paper cited above are based on the duration during which both the patient’s self-assessment and the investigator’s assessment were none or mild. I.e. for this set of K-M curves, the curves moved rightward without stepping down at a given time point for a given patient if either the patient or the investigator assessed the patient as no longer having none-or-mild status.

Because the 4-step wrinkle-severity scale we are referring to is somewhat subjective, the self-assessment of a patient at a given time point is not always congruent with the investigator’s assessment of the patient at the same time point. Clearly, the duration of none-or-mild status will be longer when it is measured by the longer of the two assessments (as in Fig. 5) than when it is measured the shorter of the two assessments (as in Fig. 2 and Fig. 3).

The complaint from the National Consumers League boils down to the distinction between the two ways of calculating duration, as described above.