Cassava Sciences Inc (SAVA)

[runncoach]

Setting aside it was an open label study with folks promoting the drug on social media in a way that is likely not beneficial, the real problem is the trial design has potentially set the final top line results up for failure. Today's results continued to enforce this thesis. The current trials include patients with MMSE between 16-26. The bottom half of those scores are the moderate ones who scored even worse than what was to be expected (-11) on today's data. We don't know how many will be in each group but it would seem unlikely that even if the mild patient group stabilizes as we saw today, it would overcome the moderate patients in a stat significant way. There is no doubt in my mind that the two groups scores will be broken out in a pre-specified but post hoc fashion that will satisfy many but could be piled on by naysayers and could take awhile for the FDA to sort things out, especially considering it will take the 2nd trial an additional 6 months to complete.

I am hopeful that the mild group is highly stat significant and that the FDA will allow SAVA to go down this path since there are nearly 2000 patients total in the 2 trials, making the mild group significant in numbers. Will be interesting to see how it plays out. JMHO