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10:59
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Originally posted by TerribleTadpole
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FDA isn't going to happen any time soon. Realistically you'll be waiting about five years for that. From the December 2018 announcement "Neurotech announces new direction for US market":Neurotech said it had several discussions with the FDA since submitting its De Novo application andthe latter advised that the protocol design and data needed to be revised and expanded to meet therequirements for a De Novo application. They also recommended that the best option would be towork with them to update the protocol and create a new study in the US. While this decision willimpact the Company’s US market entry for Mente Autism, Neurotech said it welcomed the feedbackand opportunity to work with the FDA to meet the requirements of a new study design. must
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Yes, of course. Silly me, I had read that announcement and read other posts here mentioning that, but this morning it has slipped my mind. Happy to be corrected.
