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Posted On: 08/06/2020 10:13:08 AM
Post# of 153941
Interesting Proactive and some "notes":
NP doubled down on the release of the p-values and efficacy studies. This is important as we all have our doubts about AMAREX "farming the data" in absence of primary end-point efficacy.
Apparently this is not the case and we can expect good results and, even more, show/demonstrate an accelerated timeline for recovery.
LJ mentioned once more the SEAs. This can directly be correlated with efficacy. Why ??? If a patient has SAE, for example he goes into the need for oxygen, the fever, myalgia, dyspnea and cough scale will go higher for this patient. At least dyspnea and cough will be maximum and fever and myalgia might be there (as opposed to Leronlimab).
My point being: a person with SAEs will score higher in the primary endpoints. The fact that Lero had less SAE's means we had less points in symptom scale.
Not to mention: Time to clinical resolution (TTCR) at day 14 (the first secondary outcome).
The question is statistical significance. Let's hope we will be there. FDA is under a microscope weighting a Ton. If we have statistical efficacy I cannot see an scenario in which we don't get EUI or approval with follow-up P4
In regards to CD12 the DSMC continuation of trial "as is" is good news, there had been several deaths. Now we know they we have not "caused" by Leronlimab, or at least, that Lero is not causing any deterioration of patients.
Once again, we need to be patient and wait few more weeks (I have waited already several years
). The interim analysis will calculate the p-values and other parameters. At that point CYDY might decide to present the data to FDA if it is very good. Or, simply, wait for trial termination, solidify the results and request approval.
NP doubled down on the release of the p-values and efficacy studies. This is important as we all have our doubts about AMAREX "farming the data" in absence of primary end-point efficacy.
Apparently this is not the case and we can expect good results and, even more, show/demonstrate an accelerated timeline for recovery.
LJ mentioned once more the SEAs. This can directly be correlated with efficacy. Why ??? If a patient has SAE, for example he goes into the need for oxygen, the fever, myalgia, dyspnea and cough scale will go higher for this patient. At least dyspnea and cough will be maximum and fever and myalgia might be there (as opposed to Leronlimab).
My point being: a person with SAEs will score higher in the primary endpoints. The fact that Lero had less SAE's means we had less points in symptom scale.
Not to mention: Time to clinical resolution (TTCR) at day 14 (the first secondary outcome).
The question is statistical significance. Let's hope we will be there. FDA is under a microscope weighting a Ton. If we have statistical efficacy I cannot see an scenario in which we don't get EUI or approval with follow-up P4
In regards to CD12 the DSMC continuation of trial "as is" is good news, there had been several deaths. Now we know they we have not "caused" by Leronlimab, or at least, that Lero is not causing any deterioration of patients.
Once again, we need to be patient and wait few more weeks (I have waited already several years
). The interim analysis will calculate the p-values and other parameters. At that point CYDY might decide to present the data to FDA if it is very good. Or, simply, wait for trial termination, solidify the results and request approval. 
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