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Re: Bud Powell post# 69734

Sunday, 07/24/2016 10:35:59 PM

Sunday, July 24, 2016 10:35:59 PM

Post# of 460699
Always a counter to the thinking that off-label prescribing will become rampant. Approval process, Orange Book entry, good prescribing practices, etc all protect the physician from, otherwise, very rampant libel suits. They don't just say, "Here, try this!".

7-year ODE in the rare indications could be crucial to wringing A2-73 for all it's worth. Diligent pursuit of the PCT protection and clinical development in epilepsy could add billions to the bottom line. Any reduction in gross seizure rate will be welcomed. I have witnessed, first hand, the effect of S-1 agonists on epileptics. A clinically administered dosing regimen of such potent modulators is imperative. Anavex has the correct methodology.

Every move that lends more credence to the idea of a blanket CNSD therapy raises the level of possibilities. Many other catalysts could be set to pile on in the event of something such as BTD.

Making doctors and patients more comfortable with alternative therapies is part of the Mixed S-M advantage, if there is a wide margin of safety. Attenuating cholinergic and NDMA side effects, allowing for more potent combo therapies, could be a supreme advantage to this new class of drugs.

If a next phase trial armed 30mg A2-73 + 20mg don vs 10mg don + placebo in mild AD patients over 28 weeks, I think the outcome difference would be staggering.
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