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06/10/16 7:59 PM

#64172 RE: Doc logic #64143

modeling is difficult to get right



Quite right... I'm not a stats person (AT ALL)... but one thing I'm pretty sure wasn't accounted for in all of the earlier modeling discussed was that even though the trial began again around May 2011... by November 2011... I believe they were in the process of moving the trial from a P2 to a P3. I'm guessing there may have been another screening hold during that time.

And I recall RK finding buried somewhere in an SEC filing from that time that only 6 or so patients had been added the trial by Feb 2012. At the time, that made so little sense. But if they had halted screening from November 2011 to May 2012 while the trial transitioned from 2 to 3... it makes more sense.

And then add in the approximate 3 month pipeline ... and it makes even more sense that number was so low. I believe those variables were not accounted for in any past modeling because... and I'm guessing here... no one really knew that there might have been a screening halt in that earlier time period.

And back to your point... perhaps if some of the later patients enrolled were subject to TFF manufacturing of their vaccine... and are seeing better benefits that before... that would definitely add a new, but possibly better, twist to the tale.