Christine Corrado: Hello there, Welcome back to Pr
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Posted On: 05/03/2022 9:43:14 PM
Christine Corrado: Hello there, Welcome back to Proactive NY. With me this morning is Nader Poorhassan, CEO at CytoDyn. Nader, good to see you. Happy New Year. How are you?
Nader Poorhassan: Happy New Year. Good to see you. I'm doing great. Thank you.
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.
Nader Poorhassan: Happy New Year. Good to see you. I'm doing great. Thank you.
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.
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