Wolf I very much enjoy reading your musings, thank you.
I just wanted to add to your last post that in exceptional circumstances like these where there is a large unmet need--in the case of AD it could safely be called a crisis--the FDA can not only allow fast track status they can actually approve drugs on the basis of Phase II data. It's not done often but it does happen.
The main reason this does not occur more frequently is because safety issues appear in larger studies(Ph3) that do not emerge in smaller ones(Ph2). In Bryostatin's case since the drug has been around for 30 years and the safety issues--very minor--are already well characterized, that would not seem to be an impediment here.
So while it is pure speculation on my part to suggest the FDA might green light Bryostatin on the basis of a Phase 2 trial, it is not out of the question and nor would it be unprecedented.
In any event, the past couple of months doing my research and getting to know this company has been a real pleasure, with one positive upside surprise after another. Reading Alkon's papers is like following a scientific detective story, where the truth turned out to surprise everyone, the principal researcher included.
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