actual sasquatch sightings to PBA cases is?
*Do you think people that believe in sasquatch would also believe Nuedexta is the "aspirin of the brain"?
*Do you think SSRI's are typically cheaper than Nuedexta?
*Do you think it is folly that AVNR is pursuing the current dementia study with Nuedexta without qualifying whether the patients in the study have PBA or not?
*Do you think Mr. Winkles defamed the character of Dr. Katz?
Great to see you here still trying to educate the uneducatable Ray....(kind of like sisyphus trying to roll the stone up the hill)
Always great to have you here.
You bring up the excellent point that Alzheimer's patients with PBA are apparently NOT being excluded from the agitation in Alzheimer's study!
If agitation in dementia ever gets to the point of an End of Phase 2 meeting, and if there are patients with PBA in the agitation in dementia studies--I think the FDA is going to largely discount
any alleged efficacy.
I note that PBA is NOT included in the Exclusion Criteria, as per the clinicaltrials gov site
"Key Exclusion Criteria:
Patient has other type of dementia (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia).
Patients with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g. malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, certain cardiac conduction abnormalities including QTc prolongation, or unstable valvular heart disease).