Doc, the problem is that few trials end with results that leave no doubt. I've got to believe that many here beside Missling thought the results were sufficient to gain approval. I suspect a different panel, like those that constituted Alzheimer's Europe, might have gone the other way.
Frankly I wonder if their second drug isn't better than the first and perhaps should be emphasized, but a better designed trial should also be initiated.
I'm at an age where all too many of my friends are dealing with either diagnosed Alzheimer's, or an undiagnosed form of dementia, but clearly something would be better than continual decline. I believe the regulators could have done it, and had a confirmational trial, but instead it will probably be next decade before enough data can be gathered to submit and get a different decision. I really don't know that today our FDA might not offer an easier path to approval.
The question is do they wait for more data, or do they try again before the end of the year.
Gary
Bullish
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