Company webpage for Anavex Plus states that the next trial, phase 2b, has the potential to be pivotal (i.e., to stand in for phase 3 if the efficacy is shown to be great enough). In that scenario, Anavex would then skip phase 3 and do a so-called phase 4 trial while product sales were ongoing. If 2-73 results in that phase 2b trial (which will be double-blinded, placebo-controlled, and powered up to 300 patients so as to ensure statistical significance) continue the trend observed in the interim data from the 2a trial so far, I like the chances of that trail proving pivotal for the FDA very much. Time will tell, but Alzheimer's is obviously one of those diseases where the FDA looks to fast-track medications that demonstrate breakthrough efficacy.
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