Replies to post #692202 on NorthWest Biotherapeutics Inc (NWBO)

[Horseb4CarT]

Sawston passed inspection with flying colors, so I would assume easy final inspections!

[JFR161162]

For the GBM MAA, the Company anticipates that the review process will be a period of intensive and extensive further work involving responding to questions and requests for further information by the regulatory authority as well as preparing for and undergoing detailed inspections of the contract research organizations (CROs) that managed the trial, the Sponsor, the Trial Master File, a number of individual trial sites selected by the regulator from among the 94 sites that participated in the trial, the GMP facility and manufacturing information.

[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.