Quite Logical. Might one deduce that a reason that Human trials are needed is to uncover effects separate from the neuron mitochondria and endoplasmic reticula effects in humans in systems not as identical to murine subjects as in humans as is the neurons? Is there some truth to this?
Or effects that maybe existed in the rats and mice but could not be detected in them? The rats and mice for instance can not tell the researchers they are dizzy or have an insufferable headache.
However, am I wrong to assume that such a unfavorable outcome is made less likely by the Phase 1 safety and the Phase 2a, part A and B results thus far?
I do believe the researchers were genuinely surprised at the effects in Alzheimer's patients with insomnia of relief thereof, as well as a list of unexpected 'quality of life' type observations of the caregivers and expressed by the patients themselves. Many of these of course they would not tested or observed in the murine subjects.
Of course a larger trial would be necessary to discover any AEs that might appear in a rarer case of the range of human reactions to the drug. Such as is it contraindicated in certain circumstances, for instance an Alzheimer's patient that also suffers severe depression.
Clearly A2-73 has shown beneficial effects, possibly what the next Phase needs to do is disprove placebo effect and to fully define the Drug's 'Official FDA Label' together with contraindications and possible warnings, if any.
Thanks in advance if you can take the time to answer my query.
LONG AVXL>
