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Re: Single Stock post# 657749

Thursday, 12/21/2023 10:39:35 AM

Thursday, December 21, 2023 10:39:35 AM

Post# of 689163
If yo read this

"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"



Then its clear NWBO is anticipating an RFI period (Request for Info) from the MHRA. The timeline anticipated can THUS then be set to 80 days for review and then 60 days for NWBO to answer questions from the RFI and then finally 70 days for a final decision setting the timeline to 150 days + clock off period of 60 days to end July 2024
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