I have taken some time to put my thoughts in order
Post# of 148165
(Total Views: 1125)
Posted On: 07/31/2020 10:22:14 AM
I have taken some time to put my thoughts in order. Let me say first that I was wrong (and disappointed) in that I was expecting the efficacy data to be announced yesterday.
Which begs the question “why was this meeting called?”. Or, as I always ask myself: what did NP and the team wanted to convey to us shareholders ???.
I don’t have a clear answer.
NP sounded optimistic as is usually the case (and should be). And he confided positive results:
A couple of thoughts here. The most difficult condition to treat is the mild as often patients cure by themselves. We know this and was stated by Dr. Kelly as well. In an extreme case, let’s assume Leronlimab is so good that at day 3 the patients are all cured and go back home. And in placebo at day 14 most physiological condition had resolved by themselves and they are at home. What is the difference (placebo vs Leronlimab) at day 14 ?? small and not statistically significant.
As a reminder, our primary outcome measure is: Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) [ Time Frame: Day 14 ]
And one of the Secondary outcome measure is: Change from baseline in National Early Warning Score 2 (NEWS2) [ Time Frame: Days 3, 7, and 14 ]
This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). Higher scores mean a worse outcome.
For more information on NEWS2 score visit:
https://www.cebm.net/covid-19/should-we-use-t...mary-care/
My first thought is then, that we will have difficulty demonstrating efficiency at day 14 (primary end point). Why??? because is difficult and because Leronlimab works very well (at day 3 vs day 0).
So, how do we tell (demonstrate) FDA that the drug works?? Precisely by pointing out that at day 3 there is a difference. Thankfully there is the secondary outcome measures which have time-progression timelines and that is precisely why NP was saying that:
And Dr Kelly:
And my second thought, which stems from the first one is that this is why we are taking about THREE indications now: mild-to-moderate, the moderate-to-severe, and the severe-critical. Note the new split between mild and moderate. The reason is embedded in the elucidation above.
In conclusion: When NP says “the data is still being evaluated to find more positive aspects ” he is saying: “we have found that the primary end point for mild-moderate at day 14 won’t really convey the effectiveness of Leronlimab and we will need to discriminate between severity of conditions and recovery timeline in order to better demonstrate it to FDA”
Which begs the question “why was this meeting called?”. Or, as I always ask myself: what did NP and the team wanted to convey to us shareholders ???.
I don’t have a clear answer.
NP sounded optimistic as is usually the case (and should be). And he confided positive results:
Quote:
So, in regards to the results of RCD-10, as of today, we do have positive efficacy results in RCD-10 and the data is still being evaluated to find more positive aspects. In regards to our primary endpoint, clinical improvement was scored in four categories: fever, body aches, difficulty to breathe, and cough. We have seen improvement in day 3 versus day zero in leronlimab arm as compared to placebo arm.
A couple of thoughts here. The most difficult condition to treat is the mild as often patients cure by themselves. We know this and was stated by Dr. Kelly as well. In an extreme case, let’s assume Leronlimab is so good that at day 3 the patients are all cured and go back home. And in placebo at day 14 most physiological condition had resolved by themselves and they are at home. What is the difference (placebo vs Leronlimab) at day 14 ?? small and not statistically significant.
As a reminder, our primary outcome measure is: Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) [ Time Frame: Day 14 ]
And one of the Secondary outcome measure is: Change from baseline in National Early Warning Score 2 (NEWS2) [ Time Frame: Days 3, 7, and 14 ]
This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). Higher scores mean a worse outcome.
For more information on NEWS2 score visit:
https://www.cebm.net/covid-19/should-we-use-t...mary-care/
My first thought is then, that we will have difficulty demonstrating efficiency at day 14 (primary end point). Why??? because is difficult and because Leronlimab works very well (at day 3 vs day 0).
So, how do we tell (demonstrate) FDA that the drug works?? Precisely by pointing out that at day 3 there is a difference. Thankfully there is the secondary outcome measures which have time-progression timelines and that is precisely why NP was saying that:
Quote:
The secondary endpoint are just as important as primary endpoint. This is a Phase 2. This is proof of concept. So, when you do Phase 2 with FDA, then you do Phase 3.
And Dr Kelly:
Quote:
Yeah, I do want people to understand, you know, when we're looking at covid-19 dealing with three different categories: the mild-to-moderate, the moderate-to-severe, and the severe-critical population. As we continue to learn more about covid-19 in real-time. This is what we are learning most of the mild-moderates will clear the virus on their own and will do fine.
Where we worry the most is the progression to the moderate-severe category and to the severe-critical category. Can we prevent the mild-to-moderate from getting worse and ending up on a ventilator? Can we affect the mortality rate in a severe-critical population, and can we prevent and reduce hospitalizations? This is where we believe, based on our emergency INDs that we will have the most effect.
And my second thought, which stems from the first one is that this is why we are taking about THREE indications now: mild-to-moderate, the moderate-to-severe, and the severe-critical. Note the new split between mild and moderate. The reason is embedded in the elucidation above.
In conclusion: When NP says “the data is still being evaluated to find more positive aspects ” he is saying: “we have found that the primary end point for mild-moderate at day 14 won’t really convey the effectiveness of Leronlimab and we will need to discriminate between severity of conditions and recovery timeline in order to better demonstrate it to FDA”
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