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nidan7500

11/22/17 9:05 AM

#131464 RE: Investor2014 #131461

Investor, thanks for your thoughts. I also agree

The pass criteria, endpoints, will be agreed upfront with the FDA and noted in the trial protocol

.

The continuous struggles at managing complexity (even with year old results) are marginally helpful at best. The answer needs to be, let's not make this any more complicated than it has to be, FDA protocol is key.

XenaLives

11/22/17 9:07 AM

#131465 RE: Investor2014 #131461

The FDA may not wait till "final trial readout".

blu_1

11/22/17 2:34 PM

#131522 RE: Investor2014 #131461

Endpoints being to score as good or better than any of the 5 approved AD drugs on the market? Even if scores weren't quite as good as, say, donepezil, if the side effect profile was much better and it helped AD patients with sleep and mood, might that be enough? Memantine and the other similar drugs, weren't those approved after donepezil was approved? Didn't they have worse scores than donepezil? After all, to this day, donepezil is still the SOC. But those other drugs got approved anyway.