Tuesday, January 09, 2024 1:28:37 PM
As previously reported, coronavirus-related difficulties have impacted most aspects of the database lock and the process of analyzing the Phase III trial results, especially with the successive waves of COVID-19 cases in many areas. The independent service firms have had limited capacity, and restrictions on operations. Key experts at certain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. Clinical trial sites have not allowed personnel from the contract research organization managing the trial, or other service providers, to visit the sites for trial matters such as data monitoring and collection activities. Clinical trial site personnel have been unavailable due to being reassigned for COVID-19, and the limited site personnel have had to work under restrictions. Committee processes and regulatory processes have been similarly focused on COVID-19 matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples that are needed for certain analyses, and the firms conducting the analyses have had only limited operations. Even logistical matters such as the shipping of materials have been subjected to substantial restrictions and delays.
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001072379/000141057822003073/nwbo-20220930x10q.htm
When did NWBO get the official notice on the acceptance of the JAMA paper? August 27, 2022. Keep in mind this is the official acceptance date. The informal one sent to the authors most likely would be two weeks earlier which could be the mid-August. You see my point?
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