“Accordingly, the Company is aiming to proceed with data lock at approximately the end of next week.”
MOST PERTINENT INFO FROM END OF 10Q:
“Despite these difficulties, the CRO has completed the final monitoring visits to the trial sites (including a number of them virtually), and has completed the collection of Case Report Form (CRF) data for all patients in the trial. The CRFs contain most, though not all, of the data required for analyzing the trial.
Since the Company’s prior updates, the CRO has also completed the Source Data Verification (SDV) for all of the data contained in the CRFs. Further, the CRO has completed the resolution of the many queries.
The independent service firms have also collected most of the additional data that is not contained in the CRFs, such as additional MRI scans and certain genetic information. The Company is consulting with its advisers to obtain their support for proceeding with initial data lock without waiting for these additional data, and then to include these additional data in the database when they are available.
The primary focus for reaching data lock now is obtaining the trial sites’ data locks. In order to reach overall data lock for the trial, each site’s data must be locked. Preparatory steps must be completed at each site so that the site is ready for sign-off, and then the lead investigator at the site must personally sign off on the data from that site. To that end, the lead investigator must undergo a brief training on the system, review the site data/CRFs and personally complete the confirmation and submit it.
Since the Company’s prior updates, the CRO and service firms have completed the preparatory steps for all but about ten of the sites to be ready for the investigator’s sign-off. Among the sites who had reached readiness for sign-off, about 33 sites are in varying stages of accomplishing their sign-offs and the rest of the sites have completed theirs.
The independent service firms are pressing to obtain the rest of the site completions and investigator sign-offs. The Company hopes they will be completed by approximately the end of next week. Accordingly, the Company is aiming to proceed with data lock at approximately the end of next week.
As previously reported, upon data lock the independent statisticians will be given access to the clinical trial database containing the raw data, and will undertake the applicable calculations and analyses. As previously reported, the Company will remain blinded until the statisticians have completed these calculations and analyses. That process is expected to take several weeks. The Company will then receive the initial results from the statisticians and become unblinded. Then the Company will consult with its Scientific Advisory Board, trial Steering Committee and expert advisors about the data, and address their questions and/or comments to prepare for announcement of the data.”
