Thanks much Figgs. Before this, on the 12/14/21
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Posted On: 06/23/2022 5:34:18 PM
Thanks much Figgs.
Before this, on the 12/14/21 CC we heard:
You've posted what NP told us in the PR on 1/5/22.
CR was equally excited about that time on 350, but was also very hopeful for 700.
Soon there after NP had a interview with CC on Proactive where he said:
This took place before he saw the 700mg data.
This means the partner he was referring to was only looking at the 350mg data which was good enough. 14 weeks is very short and patients could expect twice that or 3 times that time period to definitively treat this disease. A partner funded Phase 3 study, would potentially be over a period of 42 weeks.
Then on 3/31/22 CC:
This was well into the discovery of the 700mg NASH data and it hasn't had an effect at all. Why not? 350mg is good enough to take us to next phase.
Lot's of things coming in the next few days:
Hopefully a PR like Figgs says before Saturday.
Then Saturday comes and the liver conference.
Or will the PR come after the liver conference?
Maybe 2 PRs?
Then a week from today, the next conference call to discuss the PRs? or what SK mentioned at the end of the last CC? and then that Friday is the last trading day before a long weekend.
Let's Go
Before this, on the 12/14/21 CC we heard:
Quote:
Kelly: 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.
You've posted what NP told us in the PR on 1/5/22.
CR was equally excited about that time on 350, but was also very hopeful for 700.
Soon there after NP had a interview with CC on Proactive where he said:
Quote:
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. Cancer, the same thing, when we going to update the numbers so we can get that moving and the BLA HIV and Covid 19. With that plan for 2022 and all the milestones laid out, we will do a fund raising based upon that and we believe it will be very successful and a very successful 2022.
This took place before he saw the 700mg data.
This means the partner he was referring to was only looking at the 350mg data which was good enough. 14 weeks is very short and patients could expect twice that or 3 times that time period to definitively treat this disease. A partner funded Phase 3 study, would potentially be over a period of 42 weeks.
Then on 3/31/22 CC:
Quote:
Potential Partnerships: 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,
2) looking for partners in Multidrug resistant HIV,
3) partners to complete the BLA submission with Inhouse BLA expertise,
4) we are looking at partnerships in HIV combo both internationally and domestically.
5) partnerships with 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.
Market is growing at 58.64% annually. Expected to be $180.9billion by 2028.
In oncology, we are pursuing partnerships in unmet medical needs and quicker paths to approval. We do know that CCR5 is present on many tumors that are unmet medical needs as well as the tumor micro environment. Cancer immunotherapy is projected to be $277billion by 2030 growing by 12.6%. Focus is on Partnerships for immunotherapy combination.
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.
This was well into the discovery of the 700mg NASH data and it hasn't had an effect at all. Why not? 350mg is good enough to take us to next phase.
Lot's of things coming in the next few days:
Hopefully a PR like Figgs says before Saturday.
Then Saturday comes and the liver conference.
Or will the PR come after the liver conference?
Maybe 2 PRs?
Then a week from today, the next conference call to discuss the PRs? or what SK mentioned at the end of the last CC? and then that Friday is the last trading day before a long weekend.
Let's Go
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