News Focus
News Focus
icon url

abew4me

05/29/23 4:03 PM

#417200 RE: boi568 #417198

I'm wondering if TGD is waiting for the results from the P2b/3 OLE so that he can include them with the AA submission?
icon url

Investor2014

05/29/23 4:26 PM

#417202 RE: boi568 #417198

I think you are mixing up something here:

“The ab/tau biomarkers pertain to anyone with AD, so an accelerated approval will not care about subgroups. This makes an AA route the more attractive commercial option, in my opinion;”

It similar to saying everyone with AD have AD, so no subgroup analysis is needed.

You are missing here that not every trial patient will respond to A2-73 in way that changes the abeta/tau ratio biomarker value to indicate assumed improvement and thus reasonable likely to reflect a clinical benefit.

Maybe only a small proportion of patients exhibit a positive change in abeta/tau, for example only those that have APOE3 alleles plus this and that characteristic. Those would then be selection biomarkers in a Precision Medicine trial ensuring a homogeneous cohort of presumed responders only.