Good day to all. Keep cool. Is VERY simple ...
Post# of 148164
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Posted On: 02/02/2021 2:55:16 PM
Good day to all.
Keep cool. Is VERY simple ... what matters are the CD-12 results, period. Few have mentioned this and it is the way it is .... happens with every biotech prior to trial announcements. O way around it
The point is: what results??
All-cause mortality at Day 28 is the primary end-point. 50 or less deaths (more than 32.4%) will put us in the statistically-significant results. Meaning we get EUA and approval rapidly.
Now, let assume less than stellar result in death rate. Say we get 52 deaths in our group (25.7% death reduction). The FDA will look at the secondary end-points (Change in clinical status of patients at Day 14, 28, deaths 14 days and Sequential Organ Failure Assessment), if these show a definitive tendency towards improvement and either severe and critical sub-groups showing significance is possible we get a EUA.
Let's assume we get 54 deaths in our group. Provided there is not an excessively unbalanced distribution of patients we are out of luck with this study and will get some very useful, information from the trial to carry on with long hauler attempt.
Trial is finished and we can only wait. The only thing we can do is top-up depending on your number-of-shares objective.
I am all loaded up and waiting with optimism.
Keep cool. Is VERY simple ... what matters are the CD-12 results, period. Few have mentioned this and it is the way it is .... happens with every biotech prior to trial announcements. O way around it
The point is: what results??
All-cause mortality at Day 28 is the primary end-point. 50 or less deaths (more than 32.4%) will put us in the statistically-significant results. Meaning we get EUA and approval rapidly.
Now, let assume less than stellar result in death rate. Say we get 52 deaths in our group (25.7% death reduction). The FDA will look at the secondary end-points (Change in clinical status of patients at Day 14, 28, deaths 14 days and Sequential Organ Failure Assessment), if these show a definitive tendency towards improvement and either severe and critical sub-groups showing significance is possible we get a EUA.
Let's assume we get 54 deaths in our group. Provided there is not an excessively unbalanced distribution of patients we are out of luck with this study and will get some very useful, information from the trial to carry on with long hauler attempt.
Trial is finished and we can only wait. The only thing we can do is top-up depending on your number-of-shares objective.
I am all loaded up and waiting with optimism.
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