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skitahoe

10/28/20 1:37 AM

#323412 RE: snoopycomic #323405

It wasn't me, but the quiet period is something that another poster heard from Dave Innes. To me this means that they now have the information on the trial from their contractor, and they're preparing the TLD statement.

Writing a TLD statement is more complex than it sounds, no matter how positive the trial results may be, if even the smallest issue exists that fails to meet a goal, it cannot be ignored. In short, no matter how good it sounds, there will probably be something within it that shorts can attempt to make a case about. Personally I believe the survival benefits will undeniable, and even if something is a question, the FDA and other regulators will have no difficulty in approving the vaccine, and hopefully they'll expedite its approval.

I don't expect the TLD statement to be more than a few paragraphs, the detailed information will come from SNO. As long as results are no worse than Top 100 figures, I believe we're approvable. The good news is that data can only get better as patients live longer that the near 5 year median for the Top 100, I believe that median number may very well be near, or even above 70 months.

The quiet period will end with the announcement of TLD.

Gary