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Posted On: 12/20/2021 10:54:26 AM
Post# of 148899
Here is another webcast transcription by the same Reddit user I borrowed from in previous post. This one discusses long haulers and NASH.
12/14/21 Conference Call starting at 17:30
Nader: So the next task is Long Haulers. I was approached by Dr. Chris Recknor that he said he would really like to do a long hauler study and I said to Dr. Scott Kelly, that I'm not really big on it, but Kelly said Recknor really knows what he is talking about and you don't. So I listened to him and we started a long hauler's trial, and the results, everybody saw, 56 patients, what we got. Dr. Recknor, tell us where we are. Give us a little background about it.
18:03 Recknor: Sure Nader. The background is that in CD10, we didn't have a specific time period from when they had covid. And back when covid was first starting up and we were doing CD10, CD12, we were actually looking at LongHaulers in these patients. And, we observed that several of these patients improved after Leronlimab treatment after the unblinding happened we saw what we got and what we didn't get. So then we started looking at a LongHauler Trial, which led us to the exploratory trial which showed excellent results from symptom reduction in these patients. And we are further honing down what we are looking at with patients, the majority of problems that long hauler's patients have are cognitive fog and fatigue, and we are really going to be focusing on helping people with that. especially given the fact that Leronlimab crosses the blood brain barrier, and the Macaque studies were at 75% receptor occupancy in the brain. So we think it will help.
19:15 Nader: So, where are we with the protocol you submitted to the FDA for Phase 2 or Phase 2-3? I think they said no Phase 2-3, Phase 2. Where are we with that?
19:25 Recknor: Yeah, so the FDA gave us additional comments. They actually put it out for 3 different divisions to help and came back with some excellent remarks which we have adapted and we're getting ready to resubmit that shortly to them. And I think that helps both the FDA helping us make a better protocol.
19:50 Nader: Who is our CRO?
Recknor: The CRO is Symbio.
20:00 Nader: Thank you so much. And the next program that we will be having results and one of our main goals is NASH. Now with NASH, again, this was something, I was for that, Dr. Recknor started, we were very happy, Scott Kelly, and I was against him adding 350mg arm open label. and thank God, he did not listen to me. Dr. Kelly, always makes sure that Dr. Recknor gets his way and because of that, we now have beautiful results to submit. Now, there are some people asking questions which after Dr. Recknor gives us the details of NASH as to why we are so excited, I will ask you questions that the Short sellers are asking. But, Dr. Recknor, explain to us about NASH please.
20:48 Recknor: So NASH is fat and fibrosis in patients with liver failure and cirrhosis. We notice in animal models, that we are reducing fat in animals by 75%. So that led to us starting the NASH trial. Our primary endpoint is looking at fat reduction because that is what we saw with animals. But, in the open label, we are seeing excellent results with reduction of fibrosis. So it is that when you reduce fat, you can get some fibrosis reduction, but we appear to be doing both in the open label and soon to be locking of the database where we will see what happens with the higher dose of 700mg.
21:45 Kelly: And we know that hepatocytes contain CCR5, and we know that the cells that produce scar tissue in the liver, also contain CCR5, so we think, we work by both mechanisms, and that's what we think we are going to be seeing with the results.
22:00 Nader: And comparing this data we have so far with a normal placebo, it looks like we should be able to hit primary endpoint and secondary endpoint if you compare placebo data that I received from placebo from other trials that failed. But, some of the shorts sellers I believe, they are shorting the stock and asking questions, that is I think they are actually shorting their own brains, because they are asking something that doesn't make sense to me. So Dr. Recknor, they are saying that CT1 107millisecond drop in fibrosis is really nothing. Is that right?
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.
12/14/21 Conference Call starting at 17:30
Nader: So the next task is Long Haulers. I was approached by Dr. Chris Recknor that he said he would really like to do a long hauler study and I said to Dr. Scott Kelly, that I'm not really big on it, but Kelly said Recknor really knows what he is talking about and you don't. So I listened to him and we started a long hauler's trial, and the results, everybody saw, 56 patients, what we got. Dr. Recknor, tell us where we are. Give us a little background about it.
18:03 Recknor: Sure Nader. The background is that in CD10, we didn't have a specific time period from when they had covid. And back when covid was first starting up and we were doing CD10, CD12, we were actually looking at LongHaulers in these patients. And, we observed that several of these patients improved after Leronlimab treatment after the unblinding happened we saw what we got and what we didn't get. So then we started looking at a LongHauler Trial, which led us to the exploratory trial which showed excellent results from symptom reduction in these patients. And we are further honing down what we are looking at with patients, the majority of problems that long hauler's patients have are cognitive fog and fatigue, and we are really going to be focusing on helping people with that. especially given the fact that Leronlimab crosses the blood brain barrier, and the Macaque studies were at 75% receptor occupancy in the brain. So we think it will help.
19:15 Nader: So, where are we with the protocol you submitted to the FDA for Phase 2 or Phase 2-3? I think they said no Phase 2-3, Phase 2. Where are we with that?
19:25 Recknor: Yeah, so the FDA gave us additional comments. They actually put it out for 3 different divisions to help and came back with some excellent remarks which we have adapted and we're getting ready to resubmit that shortly to them. And I think that helps both the FDA helping us make a better protocol.
19:50 Nader: Who is our CRO?
Recknor: The CRO is Symbio.
20:00 Nader: Thank you so much. And the next program that we will be having results and one of our main goals is NASH. Now with NASH, again, this was something, I was for that, Dr. Recknor started, we were very happy, Scott Kelly, and I was against him adding 350mg arm open label. and thank God, he did not listen to me. Dr. Kelly, always makes sure that Dr. Recknor gets his way and because of that, we now have beautiful results to submit. Now, there are some people asking questions which after Dr. Recknor gives us the details of NASH as to why we are so excited, I will ask you questions that the Short sellers are asking. But, Dr. Recknor, explain to us about NASH please.
20:48 Recknor: So NASH is fat and fibrosis in patients with liver failure and cirrhosis. We notice in animal models, that we are reducing fat in animals by 75%. So that led to us starting the NASH trial. Our primary endpoint is looking at fat reduction because that is what we saw with animals. But, in the open label, we are seeing excellent results with reduction of fibrosis. So it is that when you reduce fat, you can get some fibrosis reduction, but we appear to be doing both in the open label and soon to be locking of the database where we will see what happens with the higher dose of 700mg.
21:45 Kelly: And we know that hepatocytes contain CCR5, and we know that the cells that produce scar tissue in the liver, also contain CCR5, so we think, we work by both mechanisms, and that's what we think we are going to be seeing with the results.
22:00 Nader: And comparing this data we have so far with a normal placebo, it looks like we should be able to hit primary endpoint and secondary endpoint if you compare placebo data that I received from placebo from other trials that failed. But, some of the shorts sellers I believe, they are shorting the stock and asking questions, that is I think they are actually shorting their own brains, because they are asking something that doesn't make sense to me. So Dr. Recknor, they are saying that CT1 107millisecond drop in fibrosis is really nothing. Is that right?
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.
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