NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

ski, the pre-approval inspection is performed to assure regulatory authorities that the facility listed in the marketing application can manufacture the product, and that the data submitted is accurate and complete. Regulators will look to confirm that:

* The site conforms to the application
* The site demonstrates manufacturing reliability
* The site can scale its operations
* The site uses suitable and adequate analytical methodologies
* The site is producing authentic and accurate data
* The site is in full CGMP compliance

I have full confidence that the Sawston facility will pass the inspection as they have previously, regardless whether it’s the same inspectors or not. Although it’s probably the most important, Sawston may not be the only site visited, since other manufacturing sites were used for the clinical trials. (Cognate in Memphis, and Fraunhofer IZI in Germany) Obviously those other sites haven’t manufactured a product for Northwest Bio in a decade, but scheduling these visits in a timely manner could be more of an issue in my mind, and it seems impossible to predict if they even will, or the timing.