Question - Do you think its a bit peculiar that the imaging study has no implications on the PD and PDD trials? One would think the imaging study would possibly identify additional biomarkers to be used in these trials. Thoughts?
I think that Anavex is hot on the trail of identifying biomarkers. So far I haven't seen any reason to exclude any subjects on the basis of biomarkers.
My reasoning is this: the mutated variant of the SR1 gene subjects still positively respond to 2-73 albeit not as well. In this case identifying the biomarker allows for separating out the subgroup for data analysis in the same way that excluding those subjects would do. At the same time including the sub group also allows for demonstrating that the sub group does in fact benefit from 2-73 but not as much. By having the subgrouping the strong response of the wild type SR1 subjects is not diluted in the data analysis by the mutant variant which would be the case if both type were lumped together. That is a win win situation.
I think that additional biomarkers that may be identified will be used to strengthen the application for BTD or AA since the FDA seems to like biomarkers as well as allowing for subgroup data analysis in the data.
I suppose if there is a biomarker identified that can identify very poor or non responders then that may be used as an exclusion criteria. So far I have seen nothing that looks like that.
Of course there is a boat load of data being collected on genome and gut biomes and there is no way to really guess what that will turn up.
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