Please note that this is a very high bar (16.9% de
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Posted On: 10/06/2020 7:01:15 PM
Please note that this is a very high bar (16.9% deaths in LL and 35.4% deaths in SOC).
Read More: https://investorshangout.com/post/view?id=592...z6a8KsB82t
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I'm afraid this bar is way too high for the design of this trial just as that for CD10.
LL cannot show statistically significant improvement even over placebo for Mild patients and unlikely to show it for Critical as well, let alone to show it over SOC.
According to Dr. Yang who had most of our EIND patients, LL was effective in 50-75% cases. This is short of 23% for the CD12 interim. Frankly, I don't understand the logic of the people who designed both trials. From all we know LL is most effective for Moderate, Moderate to Serious, and Serious conditions when vital organs are still mostly intact. If you have a trial for S/C patients by a microscopic company you must expect from doctors a heavy bias in favor of enrolling Critical patients rather than Serious. Why would a patient (or his family) in a serious stage agree to enroll in a trial unless SOC has not prevented deterioration of his condition into the critical stage? Add to this the progress in managing S/C cases, including those on ventilator. I fear we are going to have something like LL30-32, SOC13-15
Read More: https://investorshangout.com/post/view?id=592...z6a8KsB82t
________________
I'm afraid this bar is way too high for the design of this trial just as that for CD10.
LL cannot show statistically significant improvement even over placebo for Mild patients and unlikely to show it for Critical as well, let alone to show it over SOC.
According to Dr. Yang who had most of our EIND patients, LL was effective in 50-75% cases. This is short of 23% for the CD12 interim. Frankly, I don't understand the logic of the people who designed both trials. From all we know LL is most effective for Moderate, Moderate to Serious, and Serious conditions when vital organs are still mostly intact. If you have a trial for S/C patients by a microscopic company you must expect from doctors a heavy bias in favor of enrolling Critical patients rather than Serious. Why would a patient (or his family) in a serious stage agree to enroll in a trial unless SOC has not prevented deterioration of his condition into the critical stage? Add to this the progress in managing S/C cases, including those on ventilator. I fear we are going to have something like LL30-32, SOC13-15
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Le-Ron-Li-Mab, and they have not.
Le-Ron-Li-Mab, and they have not.