A few quotes that stuck out as positive from the call today (ducks under table lol)
1) On MHRA
-NP: "In regards to MHRA, we are still providing them information, especially about our 60 or so emergency IND patients. MHRA has shown interest to allow Leronlimab to have early access for severe and critical population, if we provide them with our 60 emergency IND patient results along with cd10 details.”
-KD: “MHRA has recommended that Leronlimab might be a good candidate for Early access to Medicines Scheme or called EAMS. Under this EAMS approval patients in the UK will be allowed to have access to Leronlimab prior to it’s full marketing authorization.”
2) On blood-brain barrier
-SK: “We have just learned that through a recent study in Macaques and HIV, that leronlimab does in fact cross the blood brain barrier and has been identified in brain tissue. Even more compelling about the story is that we were seeing essentially 100% receptor occupancy by leronlimab peripherally and 70-75% receptor occupancy in the brain with leronlimab 700mg dose administered once weekly. This allows us to have further confidence that leronlimab will have the opportunity to be successful in various central nervous system pathologies including HIV associated neurocognitive disorder, MS, CNS tumors, Alzheimers, and the recovery for strokes and traumatic brain injury.”
3) On the HIV BLA
-KD: “We have a complete understanding. We have all the levels of information that is needed to be submitted to agency.” “We have all available data at this point of time to make a successful submission to BLA and get a marketing approval for HIV indication.”
4) On NASH
-SK: “The NASH trial is moving along very well. We already have most of the sites selected and all other startup processes will be completed by the end of this week. So we are expecting central lab kits to be ready by early to mid october. So we plan on having the first patient injected around mid to late november. We will be announcing our first patient injection to the public.But I do want everyone to understand that we believe the market opportunity for NASH for Leronlimab is tremendous. It is anticipated to be a $20B industry by 2025. ”
1) On MHRA
-NP: "In regards to MHRA, we are still providing them information, especially about our 60 or so emergency IND patients. MHRA has shown interest to allow Leronlimab to have early access for severe and critical population, if we provide them with our 60 emergency IND patient results along with cd10 details.”
-KD: “MHRA has recommended that Leronlimab might be a good candidate for Early access to Medicines Scheme or called EAMS. Under this EAMS approval patients in the UK will be allowed to have access to Leronlimab prior to it’s full marketing authorization.”
2) On blood-brain barrier
-SK: “We have just learned that through a recent study in Macaques and HIV, that leronlimab does in fact cross the blood brain barrier and has been identified in brain tissue. Even more compelling about the story is that we were seeing essentially 100% receptor occupancy by leronlimab peripherally and 70-75% receptor occupancy in the brain with leronlimab 700mg dose administered once weekly. This allows us to have further confidence that leronlimab will have the opportunity to be successful in various central nervous system pathologies including HIV associated neurocognitive disorder, MS, CNS tumors, Alzheimers, and the recovery for strokes and traumatic brain injury.”
3) On the HIV BLA
-KD: “We have a complete understanding. We have all the levels of information that is needed to be submitted to agency.” “We have all available data at this point of time to make a successful submission to BLA and get a marketing approval for HIV indication.”
4) On NASH
-SK: “The NASH trial is moving along very well. We already have most of the sites selected and all other startup processes will be completed by the end of this week. So we are expecting central lab kits to be ready by early to mid october. So we plan on having the first patient injected around mid to late november. We will be announcing our first patient injection to the public.But I do want everyone to understand that we believe the market opportunity for NASH for Leronlimab is tremendous. It is anticipated to be a $20B industry by 2025. ”
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