Interims severe critical end of September I track

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Interims severe critical end of September

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I track and obsess over these details, so please don't take this personally.

It is now probably impossible for the results of the interim S/C to be known by the end of September.

From August 6 to August 12 (the date of the last CC) we enrolled only 2 additional subjects. That's just 2 subjects in almost a week. This is in stark contrast to the 2 subject per day we had achieved in the prior interval.

I won't extend this sad rate of enrollment out to its logical conclusion because we all know that enrollment is fluid and unpredictable.

I will say that on August 12 we had 175 enrolled and we needed 20 more to get to interim 195 -- and that was only 3 days ago.

For results to be available for the interim S/C by the last day of September (assuming 2 weeks for sign-off, database locking, and data analysis), the last subject would need to be enrolled and injected by this Wednesday, August 19.

So, they would have had to enroll 3-4 per day since the last CC to meet that threshold -- a far cry from the 2 per week that was just reported.

Baring a sea change in the number of new enrollments, I think we're probably looking at mid-October at the earliest.

And that's too bad, because I really wanted us to announce before Regeneron, which is currently slated for the end of September.