This idea of yours doesn’t sound reasonable. Why? Time and cost. You want AVXL to run an expensive, timely trial to basically rely on post-trial results to prove the efficacy of 2-73? AVXL may not have the cash to support that kind trial-extension if primary data isnt supportive enough.
Will we get a scientific paper with in depth dose titration and blood plasma data before the trials read out?
Will this paper provide additional information for analysis of the current trials and justification for continuing all future trials in a non blinded manner?
georgejjl Sunday, 03/17/19 11:02:41 PM Re: None 0 Post # 185564 of 185740
THINK ABOUT THIS!!!
It is not possible to titrate the dose to the plasma concentration of Anavex 2-73 during a double or triple blind trial, HOWEVER after the trial is completed treatment can be continued and the all subjects in the trial including those previously on placebo can all have trier dose titrated to a level that increase their individual plasma level of Anavex 2-73 to at least 4 ng/ml.
Imagine the results where those not responding during the trial all responding after the trial on optimized dosing of Anavex 2-73.
Titration related to each subjects size, weight and metabolism could increase the response and efficacy of Anavex 2-73.
See pages 12 and 13.
A plasma concentration of greater than 4 ng/ml would increase postive responses and efficacy to Anavex 2-73