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Posted On: 03/08/2021 8:06:22 PM
Post# of 148903
Going back through our predictions, and looking at table 4-3 in the 8-k today, some observations:
1. Glad they posted the 8-k with tables. I think this is the first time we have ever seen this type of data for any trial, including HIV (in five years).
2. I think the answers to the contest were: 80 deaths, 53 in LL arm (20.5%) and 27 in placebo arm (21.6%). (p-value = .39) (Table 4-3)
3. Over and over, we have heard, "show me one trial with severe/critical death rate below 30%." (Answer: check out CD12)
4. Table 4-6 is our "best data": {for people who were ordinal scale 2 at trial entry, the overall death rate was 30.6%; 27.9% LL and 36.8% placebo. This is the item that gives us 24% relative reduction in death rate. p-value on this is .1
5. I "won" the contest (which is why we all, collectively, lost the contest today). I projected 82 deaths; 48 LL and 34 placebo. I was one a handful to project more deaths with LL than placebo, and I still wasn't close on the actual gap. (LL was almost twice as many as placebo). Still, I had a wider gap than the others, except JLang who was working with a substantially larger pool of death.
6. This might be important. The facts are that 20.5% died with LL and 21.6% died with placebo. Folks, that is pretty close. Maybe the FDA is correct that we need more data to try and determine where LL really works. Frankly, it didn't have a discernable impact against the entire trial. If it was really good against a certain portion, that means it must have been worse against another portion.
7. Sure would have been nice to conduct a larger trial. Perhaps this is why smaller biotechs have trouble getting over the finish line. A partner could be helpful, particularly one with deep pockets.
1. Glad they posted the 8-k with tables. I think this is the first time we have ever seen this type of data for any trial, including HIV (in five years).
2. I think the answers to the contest were: 80 deaths, 53 in LL arm (20.5%) and 27 in placebo arm (21.6%). (p-value = .39) (Table 4-3)
3. Over and over, we have heard, "show me one trial with severe/critical death rate below 30%." (Answer: check out CD12)
4. Table 4-6 is our "best data": {for people who were ordinal scale 2 at trial entry, the overall death rate was 30.6%; 27.9% LL and 36.8% placebo. This is the item that gives us 24% relative reduction in death rate. p-value on this is .1
5. I "won" the contest (which is why we all, collectively, lost the contest today). I projected 82 deaths; 48 LL and 34 placebo. I was one a handful to project more deaths with LL than placebo, and I still wasn't close on the actual gap. (LL was almost twice as many as placebo). Still, I had a wider gap than the others, except JLang who was working with a substantially larger pool of death.
6. This might be important. The facts are that 20.5% died with LL and 21.6% died with placebo. Folks, that is pretty close. Maybe the FDA is correct that we need more data to try and determine where LL really works. Frankly, it didn't have a discernable impact against the entire trial. If it was really good against a certain portion, that means it must have been worse against another portion.
7. Sure would have been nice to conduct a larger trial. Perhaps this is why smaller biotechs have trouble getting over the finish line. A partner could be helpful, particularly one with deep pockets.
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