With a plan for 60 subjects to be completed in the current study it is unlikely that a positive outcome with statistical significance greater than p=.05 will be achieved. Thus it will be a repeat of the Rett trial requiring yet again another longer term, bigger dose, larger number study to reach criteria necessary for approval. No wonder there is such a low uptake into this study from those who recognise the pitfalls and limitations of study design. One has to ask what Larry Glass is hoping to achieve beyond a possible proof of concept from a short term low cost trial, other than further interest and non dilutional funding from big pharma. Let's do it properly first time!
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