We are also processing 3 articles for publication in peer reviewed journals. 1st in on HIV monotherapy. 2) HIV multidrug resistance. 3) Covid 19 Long Haulers program. Potential Partnerships: regarding HRD? looking both internationally and domestically; for 1) HIV Prep, we hope to use long acting LL, pending results of macaque study currently being done for once every 3 months injection, looking for partners in 2) Multidrug resistant HIV, 3) partners to complete the BLA submission with Inhouse BLA expertise, we are looking at partnerships in 4) HIV combo both internationally and domestically. partnerships with 5) existing agents that LL would be a great add on agent. and also with 6) HIV and 7) NASH looking to do a phase 2 clinical trial for obvious reasons. For HIV patients, they have increased risk of NAFLD and NASH compared to general population. Looking at combo therapy for NASH with LL and existing agent.
(What is this existing agent?)
Kelly 22:22, so we are in discussions, we have companies under NDA right now. we are advancing the discussions for multiple different applications for LL. But we will have to comment on that when it is publicly available to everybody at the same time.
Nader: 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".
Nader: At this time, we are so close to so many amazing milestones, that we can utilize those 200million shares and raise the funds that we need to go forward. But people have to keep in mind also that right now, a partnership for our NASH looks very very solid. We can't wait to have a call with everybody which will be in about 10 days or so hopefully and lay out all the steps on what we are doing on each one of these indications and what are our milestones. NASH, when are we expected to get the BTD? file and get the result.
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.
(What is this existing agent?)
Kelly 22:22, so we are in discussions, we have companies under NDA right now. we are advancing the discussions for multiple different applications for LL. But we will have to comment on that when it is publicly available to everybody at the same time.
Nader: 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".
Nader: At this time, we are so close to so many amazing milestones, that we can utilize those 200million shares and raise the funds that we need to go forward. But people have to keep in mind also that right now, a partnership for our NASH looks very very solid. We can't wait to have a call with everybody which will be in about 10 days or so hopefully and lay out all the steps on what we are doing on each one of these indications and what are our milestones. NASH, when are we expected to get the BTD? file and get the result.
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.
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