NorthWest Biotherapeutics Inc (NWBO)

[MasterKit]

From ASM-

So there's a trial master file. And there are case report forms that contain the patient data. There are batch manufacturing records from each individual product that's been manufactured. Overall, the documents could be in the range of 1 million pages. And these pages have to be gone through by humans and they have to be checked and checked for any gaps, inconsistencies, anything so that this body of documents, some of which will go in the application package and some of which will be supportive and have to be inspection-ready, all have to be up to snuff and pass muster with inspection by regulators.