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Wednesday, August 09, 2023 5:46:26 PM
In parallel with preparing the application for approval of DCVax-L, the Company is working with the contract research organization (CRO) and with specialized consultants on preparing the Trial Master File and sites to be inspection-ready for regulators.
https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057823001633/nwbo-20230630x10q.htm
I would have expected that the CRO completed this by now as Linda Powers brought up the trial master file at the 2022 ASM.
And just the work that we did, for example, from mid-September to the first week of December this fall, while everything else was going on that you already know, we went through a process of scanning and processing close to 0.5 million pages of trial master file, 12,000 to 15,000 pages a day for months. right? That's the scale of what's involved in putting this together.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170833757
It takes half a year for CRO to have the trial master file ready for inspection?
Do your own research. I am not providing legal or investment advice. This is an anonymous forum for entertainment purposes only. Don't trust anything you read.
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