BLA filing19 Jul 2023 08:12
Anticipated for H1 2025
Thats only 18 months !
"A BLA is submitted after an investigational new drug has been approved. If the Form 356h is missing information, the FDA will reply within 74 days. A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number."