Replies to post #369224 on Anavex Life Sciences Corp (AVXL)

[DFRAI]

I think this is the 2nd time you asked this question and no answered offered.

To me the AUC method is the more difficult to attain, but would love an answer from a clinician.

[Doc328]

I feel the 2 ways to evaluate Rett efficacy are both valid and equally difficult (or equally easy with qualitative scales) to meet. Anchoring with CGI is not much different than coprimary endpointing with CGI. The bigger difference is RSBQ AUC vs change in RSBQ from baseline to last visit

The 2 methods
(1) RSBQ-AUC with CGI anchor as Anavex proposes
(2) coprimary endpoints of RSBQ change from baseline to end of study and CGI-I change from baseline to EOS as ACAD has done and used in their NDA that has been accepted by the FDA

With a 7 week duration and only two efficacy timepoints (week 4 and week 7) the AUC method will give you a better result if week 4 RSBQ separates out from placebo more than week 7 and the RSBQ delta method will give a better result if week 7 RSBQ separates out from placebo more than week 4. If week 7 is better than week 4 both will give similar significance. With multiple measurements (i.e week 3, 6, 9 and 12) the AUC is probably superior

I actually already answered your question in February. See posts 349403, 351580, 351655