Lenti­Glo­bin con­tin­ues to de­liv­er in lat­est sick­le cell up­date as blue­bird out­lines path to ac­cel­er­at­ed ap­proval, de­spite pa­tient death

Still reel­ing from the FDA’s stun­ning re­fusal to file its CAR-T ther­a­py ide-cel, blue­bird is ea­ger to win back some cred­i­bil­i­ty with a new slice of the Lenti­Glo­bin da­ta they will be tak­ing to the FDA for an ac­cel­er­at­ed ap­proval.

To be sure, the BLA sub­mis­sion won’t hap­pen un­til the sec­ond half of 2021 — giv­ing blue­bird plen­ty of time to fig­ure out the man­u­fac­tur­ing. But an up­date pre­sent­ed at the EHA vir­tu­al con­gress has ap­par­ent­ly helped them reach “gen­er­al agree­ment” with reg­u­la­tors and boost­ed ex­ecs’ con­fi­dence.

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