Once re­ject­ed, FDA now rolls out a short red car­pet for Am­i­cus’ mi­gala­s­tat

Am­i­cus CEO $FOLD John Crow­ley must have made a very fa­vor­able im­pres­sion on the FDA as he lob­bied se­nior of­fi­cials to over­turn their re­jec­tion of his ex­per­i­men­tal Fab­ry drug mi­gala­s­tat.

Not on­ly did reg­u­la­tors just ac­cept the fil­ing for a new re­view, the agency is giv­ing it pri­or­i­ty sta­tus, cut­ting the re­think to 6 months and flag­ging a clear in­di­ca­tion that it’s an odds-on fa­vorite for an of­fi­cial mar­ket­ing OK .

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER