What I’ve been saying here all along...the Independent statisticians (IS) are still “working” the data, if they even have it at all. And, I’d bet the longer it takes the better, at least as far as leadership is concerned.
The last we heard the CRO was “arranging” to get the data over to the IS. We all now know there was no real reason for that late 10q except for maybe what they don’t want to tell us??
Show me where it says anywhere IS are working on the data. Instead they refer back to the “Arranging” PR and lecture us on procedure order, then blame Covid. Two most important paragraphs:
>>As previously reported, the data collection and confirmation process was completed by the independent contract research organization (CRO) who managed the trial and by other independent service firms, and we reached Data Lock for the Phase III trial on October 4, 2020. As explained in our prior announcements, following Data Lock the independent statisticians conduct analyses of the raw data and Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, in preparation for scientific publication and for public announcement. During this process, any questions or comments from the experts will be addressed as part of the preparation of the results for publication and public reporting.
As also previously reported, coronavirus-related difficulties have impacted most aspects of the process, especially with the resurgence of COVID 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 site personnel have been unavailable due to being reassigned to COVID-19 patient treatments or otherwise, and the limited site personnel have had to work under restrictions. Committee processes such as Institutional Review Boards and Ethics Committees have been focused mainly on COVID-19 matters, with other matters significantly delayed. 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 needed for certain final data, and the firms conducting the analytics for that final data (such as IDH mutation status), continue to have only limited operations. Even logistical matters such as the shipping of tissue slides have been, and continue to be, subjected to substantial restrictions and delays.
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