adonis
Footballguy
You're just showing your ignorance of technical scientific jargon deatils.
Weil bi releesing pawsitive deatils jest sune az their avaylibble.
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***OFFICIAL CYDY/Leronlimab Thread*** (2 Viewers)
- Thread starter This_Guy
- Start date
Weil bi releesing pawsitive deatils jest sune az their avaylibble.
FreeBaGeL
Footballguy
Charlie Harper
Footballguy
I assume it's safe to say that they know the primary endpoint results already?
He's said several times the FDA doesn't have any of this info. Is that a good enough reason not to disclose the top line results and just vaguely talk about secondary endpoints?
Capella
Footballguy
I guess I can understand that but these are wildly different times. Anything that is effective is going to get put into use.
what was the primary endpoint again? He didn’t specify primary or secondary today right?
adonis
Footballguy
Not sure if it's true or not, but NP did say that phase 2 trial endpoints are all in play, versus phase 3 endpoints which are more important as to which is the primary vs secondary. They were asked whether they should've switched primary endpoings like some other company (regeneron?) and they said because it was phase 2 it was unecessary, and that those who did were phase 3 trials.
Charlie Harper
Footballguy
adonis
Footballguy
For m/m, wasn't it a score that combined a lot of different symptoms into a total score? Symptoms included fever, fatigue, etc.
Jayrok
Footballguy
These are good highlights. So the DSMC is organized as of today and the meeting is set for Monday Aug 3. Results due sometime during the next week.
I hope the DSMC finds that the CD12 can be stopped and get those patients in the placebo arm LL. Next week could be a big week.
Don Hutson
Footballguy
Dexamethasone and tocilizumab can both be given with a subcutaneous shot. I stopped trying to look up which drugs could be administered that way when it was 2 for 2.
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Charlie Harper
Footballguy
ex-ghost
Footballguy
djmich
Footballguy
Whats so frustrating is that these guys really have no idea how to use data, or if they do they are sneaky. Generally I'd say sneaky but we've seen them be buffoons so many times on PR, etc etc that they may just be baffoons.
Polish Hammer has a good point above. They again selectively trickled out data. Why just those datapoints. Nader needed to say, I am only going to tell you the datapoints we have completed analysis on...and all the datapoints we have completed analysis on. Anything less can be viewed as hiding information. I find it hard to believe they do not have one single primary endpoint (at day 14) measured yet
Polish Hammer has a good point above. They again selectively trickled out data. Why just those datapoints. Nader needed to say, I am only going to tell you the datapoints we have completed analysis on...and all the datapoints we have completed analysis on. Anything less can be viewed as hiding information. I find it hard to believe they do not have one single primary endpoint (at day 14) measured yet
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Sputnikv8
Footballguy
Bob Sacamano
Footballguy
Charlie Harper
Footballguy
Hopefully someone can confirm, but he said something to that effect. That this is all the data that has been analyzed. Doesn't want to comment on more until everything is analyzed and they are legally clear. Still there is pause that top line results were not addressed, but I think he said "excellent top line results". Just waiting for everything to be analyzed.
It’s the same in cancer trials, secondary endpoints are great to meet, but if they primary endpoint is not met the trial is a failure.
Remember the statistics for a trial are driven by the primary endpoint. So in cancer if a drug slows progression of disease (as a secondary endpoint), but does not improve overall survival (as a primary endpoint) it is a negative trial. Though we can all agree cancer sucks and the secondary endpoint or slowing cancer is “good”.
We will see if the FDA makes an exception for Covid drugs
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djmich
Footballguy
What the heck does the bolded even mean. They're not analyzed...but I can tell you they are great. How does that work.
What is meant by topline. Is that primary endpoint. Is it SAE's?
adonis
Footballguy
Chaz McNulty
Footballguy
For anyone that watched the call, did they seem measured in the way they were hyping things up? They have to be careful of projecting great results if the actual results are pretty dismal. I was just wondering if they were genuinely enthusiastic, or if they were careful with their exact language.
-Phase I primary endpoint is safety and to find the dose to use in Phase II and III trials.
-Phase II is response (usually a single arm trial, but increasingly has a control arm). Here you are just demonstrating the drug has a reasonable response.
-Phase III primary endpoint is efficacy of the investigational agent against the standard of care (this can be placebo or active therapy). If the trial is designed as superiority trial the investigational drug must show significant improvement compared to control (at a p value of <0.05 if double sided), this means you are 95% confident the difference you see is real. If it doesn’t meet this, there is either no difference or the trial was under powered.
-Phase II is response (usually a single arm trial, but increasingly has a control arm). Here you are just demonstrating the drug has a reasonable response.
-Phase III primary endpoint is efficacy of the investigational agent against the standard of care (this can be placebo or active therapy). If the trial is designed as superiority trial the investigational drug must show significant improvement compared to control (at a p value of <0.05 if double sided), this means you are 95% confident the difference you see is real. If it doesn’t meet this, there is either no difference or the trial was under powered.
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adonis
Footballguy
NP is enthusiastic, and he's rarely measured.
He said some results were "good" and the news2 or whatever results were "very good" with what came across on the phone as a wink, a nod, a foot stomp, and a grunt. He did everything he could to convey good results, without outright saying it. However, he wasn't willing or able to state that the results were significant. That's what it boils down to. They made the case that the results they're seeing are better than anyone elses out there right now, but they came up short in saying the differences between leronlimab groups and the placebo were statistically significant. However, he strongly hinted that was the case in at least one secondary endpoint category.
Charlie Harper
Footballguy
So this is their primary outcome and honestly it looks like the secondary outcomes are actually more objective and would tell an even stronger story.
My guess now is the primary outcome didn't show statistical significance, but the secondary outcomes are just as good, if not better, at showing the effectivness of LL. If you look there's not much difference between the primary outcome and NEWS score.
Kind of a dumb design, but if they hit on every other secondary outcomes it's still golden. Don't think MD can argue with those results.
Mild to moderate Study End points
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Charlie Harper
Footballguy
adonis
Footballguy
Right, so having multiple secondary endpoints for a phase 2, and not meeting the primary endpoint, isn't a huge dealbreaker for a phase 2 trial if the secondary endpoints are great.
You would take measure of what worked, what didn't, and modify what you're looking at as your primary endpoint for the phase 3 trial which would be under much more scrutiny than the primary endpoint for a phase 2 trial - correct?
Or in this case, if the benefit is clear enough, you can get emergency approval from FDA, which it appears is what they're after. Which to some extent explains their desire to do a rigorous analysis of the data, present the top line findings, and then hand over the data with a published paper at result completion date. Can make a strong case for emergency approval at that point.
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Capella
Footballguy
That would be a reasonable approach. Just not sure they would approve a drug based on a secondary endpoint in a phase II trial - they wouldn’t in cancer.
This seems positive and enough for a phase III, just doesn’t seem like a HR for approval.
adonis
Footballguy
They wouldn't in cancer, but to treat a pandemic with a drug that shows better results than anything out there being used, they might.
adonis
Footballguy
Correct. That seemed to be on purpose. In 10 days in NP time the top line results will be released. I expect to see at least the NEWS results be statistically significant as that's the only thing he harped on by saying "very positive" rather than just positive, or better than placebo.
Capella
Footballguy
It would honestly be jaw-dropping if they didn’t, and I don’t say that just as a guy invested. If it’s safe get this stuff out there and see if it helps. We don’t have time on our side.
This was probably a smart move. If Trump hears of this they will be his favorite company
adonis
Footballguy
If it's safe, the SAE's are better than the standard of care, and the endpoints are better than the standard of care...seems like a no brainer. The last point is key, but NP was strongly hinting that this was in play. At the very least, it's another option as good as what's out there.
Charlie Harper
Footballguy
Bob Sacamano
Footballguy
See, I didn't get that. I thought it sounded like he was over the top ready to jump out of his skin.
Charlie Harper
Footballguy
Compared to previous NP where he promised interim analysis at 50 patients and had to get slapped by the research team, I think today is him showing enthusiastic restraint.
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Caesar
Footballguy
I may do this because I think there will be opportunities to buy back lower. There’s too much speculation and over-analyzing on this thing. People will get (more) impatient and start dropping it back down next week.
if I miss a huge pop, so be it.
unckeyherb
Footballguy
It sounded like whatever quantity commitment from manufacturing they’ve received previously has dropped multiple times. I don’t recall where the final number was however.
unckeyherb
Footballguy
GoBirds
Footballguy
I think this is where I’m at, sold all but 20% at this point for a nice profit. For the long play there will probably be some better entry points if covid treatment doesn’t pan out. Heck of a ride, what a call by Chet back in the quarter range.
Capella
Footballguy
At first when they started going over other results and talking about how how rough corona was, I was thinking oh god it’s a failure. He did pick up after that.
Caesar
Footballguy
I agree with this. Until then, I can see it getting up as high as 6.5 and Possibly dipping down in the high 4s. I know that’s very arbitrary from someone with very little experience, but I just don’t see it dropping back under 4 anytime soon.
ETA: I mean until we get real data.
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bshell27
Footballguy
Bluto Blutarsky
Footballguy
Caesar
Footballguy
Bob Sacamano
Footballguy
Measured as a primary endpoint globally, most of us are already rich, technically. If you're trying to reach some secondary endpoint, you're going to have to be more clear.
