Nader briefly said the penalty was .005, that is,

Quote:

---

Nader briefly said the penalty was .005, that is, we'd have to meet p<.045 at full enrollment for significance. I wonder if that was "top of the head."

---

That's precisely how I heard it. It was the functional equivalent of saying: "For example, we might have to meet P=0.045 if we unblind".

Dr.NP is not particularly strong with articulating details or numbers, so I took that 0.005 penalty number as a proxy or placeholder that likely only serves to convey the general structure of the 'cost basis' for unblinding the interim results.

In my opinion (not that anyone is asking), if the penalty is small enough to not be a material issue at full enrollment analysis, or if the penalty can be offset by negotiating a slightly larger full enrollment number, I personally would consider unblinding the interim results for 3 (three) reasons:

1. The time/value of presenting the interim analysis to ex-US countries that might have a lower approval threshold, and that are willing to approve early just to 'jump the line' to get the product -- is incalculable. We need revenue to fund other COVID and non-COVID trials, and we need global publicity.

2. The 'embarrassment factor' that will take the administration and nation by storm when the drug is approved and saving lives in countries other than the US is equally incalculable.

3. The notion that a DSMC comment of: "continue - this size benefit at full enrollment would be significant" "would vastly accelerate enrollment" is totally eclipsed by the accelerate poured on the enrollment process if positive interim results are actually released.