I went back to the June 2 announcement and tried to break it down and interpret it as follows. My comments are highlighted in red:
In light of the current status of the completion process, and the experience over recent months, the Company currently anticipates that the process (1) may be completed by about mid-June or shortly thereafter – i.e., within a couple of weeks after the Company’s anticipated schedule at the time of the Annual Meeting in April.
(1) what does process mean? Refer to previous paragraph – “The completion process includes final data collection, identification and resolution of queries, data checking and confirmation, and site sign-offs.
If some of the information that currently remains outstanding cannot be obtained by mid-June, the Company may consider proceeding with a “soft lock” of the data at that time, if arrangements can be made for the rest of the data to be included when it is obtained later. The Company plans to obtain advice from its regulatory counsel, its Scientific Advisory Board and the Steering Committee of the trial in regard to such possibilities. (This paragraph continues to refer to data collection and resolution of queries).
It is too early to determine what effect this update of the anticipated timing of data lock may have on the anticipated timing of the public announcement of data. There may be a similar update to the timing of the announcement of the data as to the timing of the data lock.
This sentence is key – it’s confusingly worded. I would read “timing of announcement of data” as announcement of topline data. I also interpret it as saying there will be another announcement IF there is delay in data lock. It does not mean that there will be an announcement of data lock. Since there has been no announcement, this implies data lock has already happened.
The steps that will take place after data lock remain the same as were outlined at the Company’s Annual Meeting. Initially following data lock, only the statisticians will be unblinded (i.e., will be given access to the database containing all of the raw data from the trial). The statisticians will need several weeks to carry out all the relevant analyses and calculations. Then the statisticians will deliver the results to the Company, and that is when the Company will become unblinded. The Company will then discuss the data with key advisors, such as its Scientific Advisory Board and the Steering Committee of the trial, and will address any comments or questions from its advisors as part of preparing the data for public announcement.
Here the company has given itself several weeks between data lock and top line announcement. So, if data lock happened towards the end of June or early July (we can assume data lock happened as anticipated since there was no announcement), then the company has several weeks to announce top line data. So then, how many weeks is several weeks? Perhaps 3-4 weeks at a minimum, and up to 6-8 weeks at a maximum. Which would mean that the company has anywhere from now until end of August to announce top line data.
They did not commit to announcing data lock. They committed to providing an update if data lock was further delayed. No announcement means no delay in data lock.
