Thursday, December 05, 2019 10:21:39 AM
I have a question about this calculation you provided: ‘By my math the “high dose” group probably consists of 4 people’. My question is: How likely is it that the dosage of all the other patients remaining in the Anavex study would continue to remain on a lower dose if a higher dose was demonstrating results?
I think that sometime ago Anavex disclosed that the higher dose, whatever that dose is, was showing better results. Is it likely that all patients in the study that could tolerate a higher dose would at some point be switched to the higher dose if the higher dosed patients were experiencing a better benefit? I say this too because I think that more than 4 patients voluntarily continued to be dosed beyond the original clinical trial date or dates.
This was not in your post, F1ash, but another poster commented on yesterday’s announcement about the analysis where Blarcamesine treated patients in Anavex’s 104 week were compared to to propensity corrected patients from the ADNI data base by saying that the study included only 32 patients when actually the 32 patients from the Anavex 104 week study were compared to patients from the ADNI data base. I remember people on this board contending that the original 32 patient clinical trial would be more meaningful if the 32 patients administered AVXL 2-73 were compared to patients treated with a placebo. One may take issue with the use of the ADNI data base patients to make the comparison made, but it is the only measure available that may be used as an indication of whether AVXL 2-73 patients fair better than patients not treated with AVXL 2-73 although the latter patients may have been treated with a cholinesterase inhibitor (Aricept) as Doc pointed out.
Lastly, another post indicated that if the other patients from the ADNI data base were being treated with a cholinesterase inhibitor that may be a negative reflection on this study because cholinesterase inhibitor patients are actually worse off in the long run. This may have some ring of truth, but I find it difficult to believe that a regulator would say that this ADNI comparative study is invalid because patients in the ADNI data base were using a drug we approved that actually harms patients. Additionally, we do not know whether the ADNI patients were administered a cholinesterase inhibitor for a limited or extended time - meaning the use of the cholinesterase inhibitor may have been terminated because it was no longer effective.
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