NorthWest Biotherapeutics Inc (NWBO)

[DJPele]

From NWBO 's Press Release:

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.

It would be safer to assume there would be an RFI, lest we disappoint ourselves with overly optimistic outcomes again.