Replies to post #710215 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

Who pays for all that travel and time NWBO or MHRA?

[branster]

From the press release on submission:
"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.

[CaptainObvious]

It seems unlikely that the trial sites would be in the same configuration they were years ago. They could interview people, but many have likely gone onto other jobs. They could look at documentation at the sites, but I would think that evidence would be included in the '1.7 million pages' that were submitted. So, I'm missing something, I guess.

Maybe CRL is still set up to mfr DCVax and they want to inspect that.

Ah... Branter's post:
From the press release on submission:
"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.