Wednesday, July 31, 2019 10:46:20 PM
If everyone knew 2-73 was safe then the FDA wouldn't have wanted the safety trial in the first place.
What we know is that 2-73 had very mild toxicity issues in the elderly population diagnosed with AD.
The much younger population of girls with Rett syndrome have a whole host of issues related to the brain chemistry problems caused by the mutated gene. These girls have developmental issues that AD subjects do not just to mention one big difference.
The safety trial is needed on the older Rett patients to establish a probability that 2-73 will not cause obvious problems for the younger, still developing Rett girls that could be vulnerable to things that mature individuals would not be subject to.
The young girls still have developing brains and bodies that offer many more opportunities for things to go wrong.
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