Lilly seeks speedy U.S. approval for its Alzheimer’s drug

Hello, everyone, and nice to see you again after a day off. We can explain our brief disappearance by way of kvelling — the shortest of our short people turned a significant page in her education yesterday and now advances to an institution of higher learning. We are still celebrating, in fact. After all, this is why G-d invented the cup of stimulation. That said, there is still work to be done. So here are a few items of interest. We hope your day goes smoothly and you conquer the world. And as always, do keep in touch…

Eli Lilly (LLY) will apply for Food and Drug Administration accelerated approval for its experimental Alzheimer’s drug this year, taking advantage of the unprecedented regulatory path established by Biogen (BIIB), STAT notes. The filing will be based on a mid-stage clinical trial that was completed in March and showed the drug slowed the progression of the disease, compared to a placebo, but it was conducted in a relatively small number of patients. At the time, Lilly planned to defer seeking FDA approval until it had results from a larger and more definitive Phase 3 clinical trial, which is now enrolling patients.

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