Follow up to investor2014s good PDD summary.
A major question seems to be, what happens to the 'early' trial patients that completed the trial while others were still enrolling. These 'early' patients could have completed the trial as early a Jan.2019!
As usual we are looking to make sense of information, where there are many unknowns!
The blinded trial, when unblinded will provide data for High dose, Medium dose, and placebo. So what is really left to study?
I will look at some key phrases in the OLE descriptions:
RATIONALE:
We want to get more information about how ANAVEX2-73 might improve cognition in Parkinson’s disease with dementia.
You will receive ANAVEX2-73 if they participate in this study. The therapeutic dose will be a target of 50mg; however, the final dose will be determined based on the your tolerance. (Also, titration noted by F1ash!)
MAIN OBJECTIVE
Continue assessing the safety and tolerability
PRIMARY ENDPOINTS
Safety related
SECONDARY ENDPOINTS
Efficacy related
It looks like the OLE will add one more data point, maximum tolerated dose, and the associated efficacy for MTD. It appears that they will titrate up to determine MTD.
After OLE, there will be three points MTD, High dose, and Medium dose.
CONCLUSIONS
It appears that they have confidence in the High and Medium dose data, as they are not being pursued in the OLE!
It appears that the High and Medium doses are efficacious, as the trial is continuing to OLE!
The initial trial should have results by mid 2020, with the OLE following a reasonable course. Still cannot resolve the 'early' completing patients question, but maybe it does not matter.
Wow, strong signals from AZ, Rett, and apparently PDD.
Thanks to Investor2014, F1ash, Doc328 for contributions.
