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Steady_T

11/11/20 10:34 AM

#282544 RE: ExtremelyBullishZig #282525

Alas, I think you are confusing the two different requirements.

The wording in the SEC document mentioned pivotal trial as being material.
This is a phase 2 trial i.e. not pivotal. On the other hand if the preliminary data was such that a P3 was not justified then it would become material by virtue of the sunk costs being lost. If the trial is good enough to justify moving on to a P3 then the FDA reporting rules become the controlling rules for reporting.

However, if there is to be a P3 it is unlikely to take a year before the P3 is designed and published on Clinical trials. The P2 data will have been analyzed and disclosed to justify the P3.