The case for unblinding is: 1. The DSMC recommend
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Posted On: 10/24/2020 11:29:38 AM
The case for unblinding is:
1. The DSMC recommendation is a very strong indication that the p-value is very good. They feel it will could be great with 62 more patients, which could allow the trial to halt early.
2. Unblinding does not halt the trial. It causes us to take a penalty on the end-point p-value. Speculation is that the new required p-value would be .045 Current indications are that we are well below that now, so no reason we should fear that number if we add the next 62 patients or are somehow forced to go all the way to 390.
3. Unblinding would allow us to present the interim data to media, other scientists, FDA and other countries. Something might "pop" in our favor.
4. This data could help us generate revenue from product sales or from grants. We really need revenue. And, any approval will open the door for other opportunities.
5. The recent approval of Remdesivir and the apparent efficacy of dexemethedone (and the potential for the Regeneron EUA) are all going to make it harder to enroll or harder to differential the value of Leronlimab in trials.
6. The "risk" is low. As stated earlier, the p-value penalty is modest. If our current p-value is not great (e.g. right around .05), we might as well find that out now, rather than wait another 4 months. If it is at this level, it isn't likely to get better, as the higher number of patients is offset by the more challenging recruiting environment and improved care options.
Bottom line - we really don't have any hard data on Covid that is useable. The 84 patients from CD10 will at best lead to another trial. We need some real data, and it is sitting there compiled and analyzed right this minute. Let's take a look and let the chips fall where they may.
1. The DSMC recommendation is a very strong indication that the p-value is very good. They feel it will could be great with 62 more patients, which could allow the trial to halt early.
2. Unblinding does not halt the trial. It causes us to take a penalty on the end-point p-value. Speculation is that the new required p-value would be .045 Current indications are that we are well below that now, so no reason we should fear that number if we add the next 62 patients or are somehow forced to go all the way to 390.
3. Unblinding would allow us to present the interim data to media, other scientists, FDA and other countries. Something might "pop" in our favor.
4. This data could help us generate revenue from product sales or from grants. We really need revenue. And, any approval will open the door for other opportunities.
5. The recent approval of Remdesivir and the apparent efficacy of dexemethedone (and the potential for the Regeneron EUA) are all going to make it harder to enroll or harder to differential the value of Leronlimab in trials.
6. The "risk" is low. As stated earlier, the p-value penalty is modest. If our current p-value is not great (e.g. right around .05), we might as well find that out now, rather than wait another 4 months. If it is at this level, it isn't likely to get better, as the higher number of patients is offset by the more challenging recruiting environment and improved care options.
Bottom line - we really don't have any hard data on Covid that is useable. The 84 patients from CD10 will at best lead to another trial. We need some real data, and it is sitting there compiled and analyzed right this minute. Let's take a look and let the chips fall where they may.
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