BrainStorm Cell Therapeutics Inc (BCLI)

[sokol]

Could be: “Due to the complexities of manufacturing biological products, a pre-license inspection of the facility is generally required before a BLA is approved. Pre-approval inspections sometimes also take place during an NDA review, but are typically conducted based on risk assessment by the Agency.”


https://www.nuventra.com/resources/blog/regulatory-differences-between-an-nda-bla/