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The Danish Dude

03/15/22 4:21 AM

#451267 RE: jimmy667 #451260

From the 10K lately about the 2021 activities. There have been some activities, that involved some kind of participation by clinical trial sites.

As previously reported, coronavirus-related difficulties continued through 2021 to impact most aspects of the activities following database lock, and have also impacted the process of analyzing the Phase III trial results and preparing to report them, 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. Other experts have gone on extended leave. 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 difficulties and delays.