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Re: anders2211 post# 349146

Friday, 01/22/2021 2:37:45 AM

Friday, January 22, 2021 2:37:45 AM

Post# of 698816
Anders,

If I understand you correctly, the invocation of the 4 day notice rule would not necessarily commence upon NWBO’s receipt of statisticians’ analysis but rather upon an NWBO determination after analysis that there were a trial failure as explained in my previous post. This is a rather novel interpretation and obviously when this failure event is disclosed by NWBO is mostly controlled by NWBO.

To wit: NWBO receives analysis from the statisticians on day 1. There appears to be failure to achieve the primary endpoint and some other endpoints. However, NWBO wants to make certain about the analysis submitted by the statisticians and begins the process of their own review and analysis with their SAB, consultants, counsel and even counsels with the regulatory agencies. This NWBO process takes 60 days. NWBO reaches a conclusion that there is trial failure. NWBO then discloses such failure on the 4th business day. Hence, from the date of receipt of the analysis by the statisticians to public disclosure is a total of 64 days but since NWBO has disclosed this material event within the 4 day window after determination of trial failure and assuming material impairment is a covered event within the 4 day SEC rules, NWBO is in compliance. However, to be sure, NWBO would be in significant control as to the timeframe within which to make the disclosure...plus 4 days. Or NWBO could decide not to disclose anything until a decision by the FDA rejecting their application believing that even though things looked bleak there still might be a chance of some sort of approval on the theory that you never know until you know from the FDA. Hence, trial failure can really only be decided by the regulatory agency. It is then that you report within the 4 day window.

Bottom line, when the clock starts running on the 4 day window depends upon when NWBO pretty much subjectively decides(or objectively by the FDA) there is a material negative event. I suppose that may be a possible interpretation and perhaps an opinion held by NWBO.

However, and again, my major point is that investors should not be guided by NWBO silence that the trial is successful. Silence is neutral and may portend a negative or positive outcome. JMHO.
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