Replies to post #692037 on NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

I don’t think it’s opposite things flipper. As I said here, the marketing application review is an interactive process where the company is sharing requested information with the various assessors and inspectors, and I think this process is what Northwest Bio spent months preparing for, and discussed in their press release. But because Northwest Bio used the language “request for further information” in the following press release, I believe that some may have misconstrued this process with an official RFI letter, which is sent to the company after the first phase of scientific assessment, if more information is needed that is not included in the marketing application and supporting documents.

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.

https://nwbio.com/northwest-biotherapeutics-announces-marketing-authorization-applications-submitted-uk-mhra-dcvax-l-glioblastoma/

The way that I read the following from the 10Q:
"The Company did not make any amendment or addition to its MAA after the original December 20, 2023 submission”
it does not appear to me that Northwest Bio received a RFI letter, after the initial phase of assessment.

[mxp1]

150 days should get NWBO approval middle of May 2024.