I forgot to mention that apart from the biomarkers, the other measurable efficacy using biology/ use of instruments is the effect of trof on seizures...this will be measured by monitoring continuous data from EEG.
From what Larry Glass said in his presentation, reduction of seizures alone is sufficient for FDA approval (along with safety of-course - which is a given)
According to Dr Google,
An electroencephalogram (EEG) is a test used to evaluate the electrical activity in the brain. Brain cells communicate with each other through electrical impulses. An EEG can be used to help detect potential problems associated with this activity.
The test tracks and records brain wave patterns. Small, flat metal discs called electrodes are attached to the scalp with wires. The electrodes analyze the electrical impulses in the brain and send signals to a computer, where the results are recorded.
The electrical impulses in an EEG recording look like wavy lines with peaks and valleys. These lines allow doctors to quickly assess whether there are abnormal patterns. Any irregularities may be a sign of seizures or other brain disorders.
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I forgot to mention that apart from the biomarkers, the other...
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