I emailed Jon and he quickly responded with:
'In the US you are not allowed to state that something is safe and effective until FDA has approved it. Prior to approval every drug is an “investigational medicine” and should be referred to as such. Acadia is just being ultra-cautious in the permanent piece on their website'.
Regards, Jon
Was pleasantly surprised with Jon's quick response wish other CEO's and or Companies were like this one. For me it appears its Neuron who is abiding by the rules by stating that its an investigational medicine.
Howie
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Ann: Rett Syndrome NDA accepted for Priority Review by FDA, page-58
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$12.54 |
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