Alzheimer's break­through? Not so fast — ex­perts poke holes in da­ta un­der­ly­ing Chi­na's sur­prise ap­proval

No new drug has been ap­proved for Alzheimer’s since 2003, and re­searchers en­deav­or­ing to change that have been greet­ed with a grave­yard of failed ther­a­pies. So when Chi­nese reg­u­la­tors waved a treat­ment de­vel­oped by an ob­scure biotech through to the mar­ket — al­beit a con­di­tion­al ap­proval con­tin­gent up­on con­fir­ma­to­ry da­ta — it makes sense that sci­en­tists who woke up to the news were more in doubt than in awe.

While sev­er­al promi­nent Alzheimer’s ex­perts threw their weight be­hind the sea­weed-de­rived ther­a­py, oligo­man­nate (GV-971), oth­ers con­tact­ed by End­points News were much more skep­ti­cal. As Green Val­ley Phar­ma has yet to re­lease full da­ta of the sin­gle Phase III tri­al on which the de­ci­sion was based, most are tak­ing a wait-and-see stance while the com­pa­ny pre­pares to launch a sec­ond, glob­al tri­al in ear­ly 2020.

Among the del­uge of ques­tions sur­round­ing the sur­prise ap­proval, two seem par­tic­u­lar­ly cru­cial: Did Green Val­ley of­fer enough cred­i­ble ev­i­dence to war­rant an OK? And did the drug re­al­ly work as the biotech claimed?

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