Some reflections before the FDA decision on whethe
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Posted On: 08/19/2020 6:22:41 PM
Some reflections before the FDA decision on whether they will grant us a EUA.
As far as we are concerned: Let’s assume for a moment that we had a p-value less than 0.05 in the TCSS scale (that is, that we met the primary end point of the P2 trial). What would had happened?? Well, the stock price would be much higher today and the wonder of leronlimab would had been heralded to the four winds. Main media, interviews, maybe even politicians would by know now CYDY and how to pronounce Leronlimab.
We did not meet this point. We met a more difficult secondary end-point. NEWS2 all treated patients @ Day 14 p=0.0233.
Where is the media?? SP ??? Politicians ???
crickets ….Fair enough, but,
As far as the FDA is concerned: Leronlimab would had filed for EUA in either case and we would be in the same situation: FDA analyzing the data, both primary and secondary end points. So, as far as FDA is concerned, we are in the same situation as if we had met the primary end point.
We run a P2 trial and we took the drug to the FDA with positive P2 results. We, CYDY, did our job. Now is time for FDA to do theirs.
It was (and is) a difficult test. Why ??. Let me quote Dr. Lalezari who participated in the trial design:
So we went to improve flu-like symptoms caused by COVID. And discovered that the subgroup that was worse (more than 4 TCSS points) @day 3, 71% of the placebo had improved vs 91% for Leronlimab. We had very little to work with !!! Let’s think about this: at day 3 7 out 10 patients in placebo were improving …
What about those with TCSS less than 4 ? well, they were probably not sick enough to be treated with a drug like Leronlimab (difficult to stablish a measurable contrast). Or, in another words, we shouldn’t have gone into “mild” treatment. And maybe into some “severe” patients:
Was the design of the trial not optimal ??? Well, it is easy to be a Monday-morning coach. The trial was for mild to moderate (M2M) , and-flu like symptoms classify as M2M. Right ???
So, we made something good out of something difficult to start with.
Also, results were confirmed by the Per Protocol Population (PPP): P<0.03 day 3 and p<0.02 Day 14.
Now, back to today: we are now in hands of the FDA. I will not discuss once more what I think about them. However, I want to remind them that they changed the end point of Remdesivir and rapidly approved for emergency once it was shown that 3 days had been shortened out of hospital stays.
Granted, we do not contribute any money to lobbyists, about 3.9 Million so far this year and $5.72 in 2019 (and to pay FDA expenses) and we do not have eight NIH Coronavirus Treatment Experts with financial ties to Gilead.
But … we are in a pandemic !!!
https://nationalfile.com/busted-eight-nih-cor...to-gilead/
https://www.opensecrets.org/orgs/lobbying?id=D000026221
The drug is SAFE. P3 are normally carried out with more patients mainly for SAFETY evaluation purposes. This is not required, we are as safe as water (well, a little exaggeration here, but you get the point). !!!!. If efficacy is the issue grant EUA with strict follow up.
Let me repeat: But … we are in a pandemic !!! and people are dying every day ...
As far as we are concerned: Let’s assume for a moment that we had a p-value less than 0.05 in the TCSS scale (that is, that we met the primary end point of the P2 trial). What would had happened?? Well, the stock price would be much higher today and the wonder of leronlimab would had been heralded to the four winds. Main media, interviews, maybe even politicians would by know now CYDY and how to pronounce Leronlimab.
We did not meet this point. We met a more difficult secondary end-point. NEWS2 all treated patients @ Day 14 p=0.0233.
Where is the media?? SP ??? Politicians ???
crickets ….Fair enough, but,
As far as the FDA is concerned: Leronlimab would had filed for EUA in either case and we would be in the same situation: FDA analyzing the data, both primary and secondary end points. So, as far as FDA is concerned, we are in the same situation as if we had met the primary end point.
We run a P2 trial and we took the drug to the FDA with positive P2 results. We, CYDY, did our job. Now is time for FDA to do theirs.
It was (and is) a difficult test. Why ??. Let me quote Dr. Lalezari who participated in the trial design:
Quote:
Treatment with leronlimab demonstrated reductions in both serious adverse events, as well as predictors of pulmonary collapse in patients with mild-to-moderate COVID-19. We initiated the study hoping to reduce flu-like symptoms, such as fever, cough, and muscle aches. In the end, use of leronlimab was not only correlated with improved symptom scores in patients with measurable symptoms at baseline, but also provided significant and consequential benefits on far more serious endpoints. Demonstrating these efficacy signals in a population with mostly mild illness at study entry bodes well for leronlimab’s activity in patients with more severe illness
So we went to improve flu-like symptoms caused by COVID. And discovered that the subgroup that was worse (more than 4 TCSS points) @day 3, 71% of the placebo had improved vs 91% for Leronlimab. We had very little to work with !!! Let’s think about this: at day 3 7 out 10 patients in placebo were improving …
What about those with TCSS less than 4 ? well, they were probably not sick enough to be treated with a drug like Leronlimab (difficult to stablish a measurable contrast). Or, in another words, we shouldn’t have gone into “mild” treatment. And maybe into some “severe” patients:
Quote:
The subgroup analysis indicates that among patients with more symptoms at baseline , those who received leronlimab had a greater treatment effect than patients who received the placebo.
Was the design of the trial not optimal ??? Well, it is easy to be a Monday-morning coach. The trial was for mild to moderate (M2M) , and-flu like symptoms classify as M2M. Right ???
So, we made something good out of something difficult to start with.
Also, results were confirmed by the Per Protocol Population (PPP): P<0.03 day 3 and p<0.02 Day 14.
Now, back to today: we are now in hands of the FDA. I will not discuss once more what I think about them. However, I want to remind them that they changed the end point of Remdesivir and rapidly approved for emergency once it was shown that 3 days had been shortened out of hospital stays.
Granted, we do not contribute any money to lobbyists, about 3.9 Million so far this year and $5.72 in 2019 (and to pay FDA expenses) and we do not have eight NIH Coronavirus Treatment Experts with financial ties to Gilead.
But … we are in a pandemic !!!
https://nationalfile.com/busted-eight-nih-cor...to-gilead/
https://www.opensecrets.org/orgs/lobbying?id=D000026221
The drug is SAFE. P3 are normally carried out with more patients mainly for SAFETY evaluation purposes. This is not required, we are as safe as water (well, a little exaggeration here, but you get the point). !!!!. If efficacy is the issue grant EUA with strict follow up.
Let me repeat: But … we are in a pandemic !!! and people are dying every day ...
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