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Re: scotty3371 post# 238299

Friday, 08/02/2019 2:13:55 PM

Friday, August 02, 2019 2:13:55 PM

Post# of 822349

What is Linda hidding?



Great results.

What does it matter Scotty, if the price goes up or down each day, unless you are selling or buying? If you're holding, you're holding for the big news, and that will come when the SAP finalization process is completed.

As to what is the official current status of SAP? As of June 4, it was "nearly complete". Beyond that is anyone's guess. As for how I interpret that, well I would like to encourage those who are not invested to keep guessing that'll it'll never be submitted, and never be finalized.

After 5 months of work with independent statisticians, the draft Statistical Analysis Plan (SAP) is nearly complete at this point. (The SAP contains all of the planned analyses for the data that will emerge from the Phase III trial.) This has been the most labor intensive stage for the Company on the road to unblinding of the Phase III trial data.



Additionally...

To save time to the finish line, the independent CRO that manages the Phase III trial has been checking and validating all of the trial data, in parallel with the Company’s work on the SAP. This involves checking all of the data points in hundreds of pages of case report forms for each of the 331 patients. The process has generated thousands of “queries” relating to any missing data or data questions, as is typical in a large trial. This task is also nearly complete, too, with only a few hundred queries remaining to be resolved.



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