Either way, we can all expect 2019 to be a big year for us.
The FDA has several times expressed its willingness to compromise when it comes to AD, so it wouldn't surprise me if this next confirmatory trial will be enough for them to approve it for the market, at least on a preliminary/conditional basis while further trials are conducted at the same time.
The FDA is also currently led by a anti-regulation, pro-free-market administration, so i doubt they'd want Bryostatin to get tangled up in too much bureaucracy.
A follow-up phase 3 (and maybe even 4) will obviously be obligatory, but I think the world's potentially first safe treatment for AD will be enough to make them reconsider taking this through the usual isolated trial process while millions of patients out there are slowly getting killed by this disease every single day.
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