My issue is those 4 sub-anchors aren't going to form a strong trial protocol for a Phase 3 study for broad use. It would be a different question if they were targeting to treat anxiety or depression in CNS conditions. The fact is, anxiety isn't a core Rett Symptom, whereas movement and hand-use is. Some Rett girls are already on SSRI's or other medications to help with that aspect. Many CNS conditions have secondary problems such as anxiety and depression and you can imagine why.
Source: The mayo clinic:
"Anxiety is considered a complication of Rett Syndrome"
Key Symptoms: Slowed Growth, Loss of Movement and coordination (ambulation), loss of communication abilities, unusual hand movements.
Communication is covered but ambulation and hand movement are essential and are easily measured.
Rett syndrome - Symptoms & causes - Mayo Clinic
Before further investment is made in the program (It takes about 50-100m USD for a Phase 3) I would want to understand what the results look with Anchors that the FDA are far more likely to accept.
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