Bluebird says gene therapy application delayed again, citing disagreement with FDA

Bluebird says gene therapy application delayed again, citing disagreement with FDA

Source: 
BioPharma Dive
snippet: 

Bluebird bio said Thursday it doesn't expect to complete an application for U.S. approval of its gene therapy LentiGlobin until mid-2021, as the biotech failed to reach agreement with the Food and Drug Administration about providing additional data for the agency's review.