"Following a successful phase 2 trial, Cassava Sciences told investors the Food and Drug Administration (FDA) gave the green light for a pair of phase 3 trials slated to begin in the second half of the year. If simufilam succeeds at both, shares of this biotech could explode higher.
Unfortunately, Cassava Sciences has been developing simufilam for over a decade and it still doesn't have any evidence from a randomized controlled trial that simufilam works as intended.
The company included a placebo group in a small phase 2 study that read out last year, but simufilam failed to reduce signs of inflammation that show up in fluid that bathes the brain. Investigators also gave Alzheimer's disease patients cognitive tests to see if simufilam actually made a difference, but they couldn't measure an improvement."
Some WS analyst are indeed going to look like fools.
Too bad there isn't another bio with multiple controlled studies showing statistical significance, practical significance (effect sizes) and clinically meaningful outcomes...and with an ad study just about fully enrolled....now that would be a one in a billion stock to find...maybe one day