NorthWest Biotherapeutics Inc (NWBO)

[TopelRoad]

How many employees work at NWBO? PR of TL data may garner money needed to hire per a gap analysis. Even successful BP slog through the BLA process.

NWBO will need to submit a Form FDA 356h to CBER or whoever handles immunotherapies - CBER is biologics. Here it is.

· A summary of information submitted as part of the application.
· Information on the applicant submitting the biologics license application.
· A preclinical data section.
· A clinical data section that includes safety and efficacy data on the product.
· Draft labeling of the product to be licensed.
· Information on the manufacturing, chemistry, and controls of the product.
· A data summary of validation of important processes and assays involved in the manufacture of the product.
· A description of the facility where the product is manufactured.
· Case report form tabulations on the manufacturer’s clinical experience with the product.
· Case report forms and serious event narratives.
· An index.

I suppose NWBO may need to submit something stating they are prepared for a BLA inspection by the FDA.

This company is snail paced and this is a large laundry list.