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Saturday, August 06, 2022 5:25:49 AM
I also note that the latest pipeline has the planned PD study as a P2 rather than a pivotal trial.
The two adult Rett trials were small and both had a pretty large placebo response. Yet both trials produced stat sig outcomes.
The RSBQ and CGI both yield quite volatile outcomes being observational and subjective measures. That is still true even when attempting to frame the measures with CGI anchoring and AUC rather than just baseline to EOT.
However, with a 3rd and larger paediatric Rett trial underway and convincing readout from that, it will give context to the two small adult Rett trials.
I believe Anavex depends on a great Excellence readout to file an NDA for all ages of Rett patients. We’ll see in Q1 next year.
Recent AVXL News
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