Thanks Hottod - great to see the Phase II criteria layed out clearly and concisely.
When I previously read the planned approach from Neuren (note: I do have a hybrid medical and finance background but not to the extend of the esteemed Hottod, I admit !!) I was taken by two key points:
1) The scales and standards used specifically for the trial give me confidence that results cannot be mis-interpreted (well, not to a large degree anyway!!), with reference to other medical companies moving goalposts and/or approaching FDA approval with half-baked ideas; and
2) The optimised dose, open label, 4 indications all at once - a BIG BANG approach, if you will - to me seems to be a pathway that is very confident of a good result.
For me, point (2) is key - Neuren, like any medical company looking for FDA approval - will choose their Phase/testing methodology that provides them with the optimal chance for a successful outcome...but stays within the rules, of course, for success. For Neuren to tackle it this way - whereby IMO its harder to hide or explain a lack of efficacy - is very telling, especially when paired with the latest NEU report and the verbiage used there.
All in all, Neuren seem very confident of PhII success - time will tell how well-placed that confidence is !
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