Just plug in "ALS" for "Alzheimer's" in below news piece:
Just weeks after pointing R&D groups engaged in Alzheimer's drug research to early-stage patients, the FDA is proposing to lower the bar biotechs will have to clear in order to gain an approval. And faced with a string of blockbuster collapses in Phase III, regulators are signaling a greater willingness to offer early, accelerated approvals for the most promising therapies that come out of the pipeline.
cognitive improvements alone or preventive measures proven with biomarkers.
These new standards--initially addressed in a new draft guidance last month--could radically alter the R&D landscape for Alzheimer's drugs, widely perceived as a golden ticket to instant blockbuster status. They could also open a pathway to new therapies that could help millions of patients grapple with a mysterious and terrible disease.