first refer to here:
https://www.reddit.com/r/LeronLimab_Times/com...;context=3
part of that is here:
CC: Nader, lots to get to today. Let's kick it off with the results you announced this week for your 350mg weekly dose of LL for your phase 2 NASH clinical trial. You have some apparent positive results here?
NP: Yeah, so, whenever there is analysis, there is a primary endpoint, the most important primary focus of everybody. Primary endpoint can be analyzed on the ITT, Intention To Treat population, that means everybody who comes into the trial. Or Per Protocol, PP. That means if somebody didn't finish a trial, or just got involved for a few weeks and got kicked out, or whatever the STAP, statistical analysis plan has dictated, then you take some of the patients out based upon that violation of the protocol and so forth. That's called Per Protocol, PP. So 1) ITT and 2) PP.
In Primary Endpoint, which was PDFF, the fatty deposits, we have hit our Primary Endpoint for both populations. Primary Endpoint, for both populations of ITT and Per Protocol.
Now, lets talk about Secondary Endpoint. That's what some people had confusion. The Secondary Endpoint, when you do the ITT, then you do PP. ITT is everybody. PP is the people who didn't finish the trial and all that. The ITT which showed that we had (a "p" value of ) 0.057. So we are getting close to 0.05. and the PP was like 0.02, it was statistically significant. Now, when we do this with a different methodology, we have all of them statistically significant. Because, there are different ways of doing them. But, we don't want to talk about those things because we want the FDA to get a chance to look at it. But our share holders are very eager, they always want to see the data, so we thought to give them a good news, we hit our Primary Endpoint and Secondary Endpoint in the PP Per Protocol, but the Primary Endpoint was also hit on ITT.
Now, what does that mean for the company? Well, we are sending this TopLine Report that we are finalizing, now, immediately to the FDA and other countries and right now, we are sending it to over 1,000 people from pharmaceuticals, biotech, bigger pharmaceuticals, all over the world, because this data, to us, is going to be able to go forward with Phase 3 and BTD. We believe that. And the data has told us by the statistician and the group that did this analysis, that it is "hands down", "very strong data". But again, we don't want to get to this 0.057. Why wasn't that one statistically significant for secondary endpoint in the ITT group? We can look at it other ways. I have data here that shows certain ways that you can analyze to get better. We did it very conservative. We gave it to a 3rd party. The folks were solid. They have generated all the tables. And we feel very strong about the data.
CC: OK, let's move on from NASH, to your Corona Virus Trial. In the past weeks, you've said you would start your Phase 3 to evaluate LL in Corona Virus in Critically Ill Patients. Have you started that yet?
next refer to the December 14,2021 Conference Call here:
https://www.reddit.com/r/LeronLimab_Times/com...;context=3
36:10 Recknor: I did Nader, One thing, in keeping with the reduction in fibrosis that we are seeing, these Long Hauler patients, and perhaps, this is the signal of all post viral syndromes, have a lot of Fatty Deposition in the Liver and in the Pancreas. Also, there is cardiac involvement as well. And so we are incorporating, with this signal that we are seeing, with reduction of fibrosis, we think that we will be able to do this systemically. And we are incorporating that in evaluation of our trials as well. and I think its important to not only have a subjective patient reported outcome, but also objective measures, in terms of cognitive testing, MRIs, etc.
37:10 Kelly: I would like to mention, I just recently presented at the World antiviral conference on November 30th. we covered a lot of ground in that. HIV mono, HIV prep, HIV cure project, combo therapy, covid 19 critical, LH, NASH and oncology and I think there is a growing interest in LL as a platform molecule across multiple indications and I think what that is going to do for us is that in terms of partnerships, we just brought back Dr. Brendan Rey who worked with us in the past and now that we have data, Brendan is an attorney with virology experience and we are going to be looking at partnership opportunities not only with domestic, but also China, Argentina, Taiwan, South East Asia, Mexico, Turkey, Korea. We are looking at multiple different things like oncology, HIV, NAFLD, NASH, so I think it's really exciting where we are going going into this new year.
38:05 Nader: Absolutely, and the last, if the NASH trial is as strong as what we believe, when we unblind it, let's just say, that with the open label, we hit our primary endpoint and secondary endpoint, we will immediately file those results with MHRA UK, Health Canada, Brazil and Philippines, cause they have pharmaceuticals over there that we are working with. So this is going to go to a whole new level if we have a primary and secondary endpoint hit in either the open arm or the unblinded, but we will be reporting on that hopefully very soon.
and lastly from here:
https://www.reddit.com/r/LeronLimab_Times/com...;context=3
22:44 Recknor: That's a huge decrease in patients. and this study that we did, did not look at biopsy, (that would be for the Phase 3 study), but we wanted something that would be quick, that we could get results back and look at through 350mg vs. 700mg, to see if we had a signal. And when you do biopsies, you are looking for about a 40ms drop change, 80ms, you are going to get biopsy changes, changes that represent the decrease in that CT1. Actually, I think we are going to get an accentuation of the biopsy results in the phase 3. So 80ms is phenominal, the most impressive thing though is that this is in the severe, we are seeing this in severe patients where we didn't previously think you could get resolution of fibrosis.
23:40 Nader: And the Data we said in the title was 80% of the patients were 50ms drop and 50% had 80ms drop average. Now, somebody sent me a question thinking I was writing a poem and I was trying to match the poem, I wasn't do that. This is the results. And this is what we are going to be showing to the FDA as soon as the rest of it is unblinded. Tell us about the unblinding and when we will have that. Cause that is a huge event for us because of what we are seeing in the open label.
24:17 Recknor: We are working on database lock right now. Shortly thereafter, we are looking at before Christmas vacation, being able to produce a topline report. And this gives us the ability to look at what's going on with the 700mg dose, which I'm very excited to see, and looking at the 350mg dose, as compared to the placebo, in the double blind portion Part 1, so we are really excited.
24:47 Nader: Yeah, and some people are saying in other NASH trials, they do a 1,000 patients, so we probably need a partnership, with 1000, 2000 or 10 patients, if you hit your primary & secondary endpoint, that's a huge deal. We don't know what we have, cause we haven't unblinded it yet, but we are really waiting to see how that comes out.
OK, I see your point about partnering with another pharmaceutical on NASH when we have excellent results. Yes,
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