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Post by mango on Jan 12, 2021 10:45:40 GMT -5
✅ Receptor Life Sciences wild card in play ✅ The meeting resulted in clear guidance on the regulatory requirements for the development and approval of RLS103 under section 505(b)(2) ✅ RLS103 is an investigational inhaled cannabidiol (CBD) designed for the treatment of acute panic attack ✅ Currently no immediate-acting products are available for panic attacks, so RLS103 has the potential to be First-in-Class ✅ Receptor will be utilizing MannKind’s Technosphere technology and inhalers ✅ RLS103 is a drug-device combination product based on the Technosphere® dry powder inhalation system licensed from MannKind Corporation ✅ This will be HUGE ————————————— My guess is the 505 (b) is through repurposing GW Pharma’s Epidiolex which is an aerosolized oro-muscosal spray. Guess a guess. www.receptorlife.com/receptor-life-sciences-receives-fda-guidance-for-development-of-rls-103
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Post by goyocafe on Jan 12, 2021 11:04:25 GMT -5
✅ Receptor Life Sciences wild card in play ✅ The meeting resulted in clear guidance on the regulatory requirements for the development and approval of RLS103 under section 505(b)(2) ✅ RLS103 is an investigational inhaled cannabidiol (CBD) designed for the treatment of acute panic attack ✅ Currently no immediate-acting products are available for panic attacks, so RLS103 has the potential to be First-in-Class ✅ Receptor will be utilizing MannKind’s Technosphere technology and inhalers ✅ RLS103 is a drug-device combination product based on the Technosphere® dry powder inhalation system licensed from MannKind Corporation ✅ This will be HUGE ————————————— My guess is the 505 (b) is through repurposing GW Pharma’s Epidiolex which is an aerosolized oro-muscosal spray. Guess a guess. www.receptorlife.com/receptor-life-sciences-receives-fda-guidance-for-development-of-rls-103I thought it was more so for Technosphere and the inhaler. Maybe it's all three.
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Post by Deleted on Jan 12, 2021 11:19:45 GMT -5
✅ Receptor Life Sciences wild card in play ✅ The meeting resulted in clear guidance on the regulatory requirements for the development and approval of RLS103 under section 505(b)(2) ✅ RLS103 is an investigational inhaled cannabidiol (CBD) designed for the treatment of acute panic attack ✅ Currently no immediate-acting products are available for panic attacks, so RLS103 has the potential to be First-in-Class ✅ Receptor will be utilizing MannKind’s Technosphere technology and inhalers ✅ RLS103 is a drug-device combination product based on the Technosphere® dry powder inhalation system licensed from MannKind Corporation ✅ This will be HUGE ————————————— My guess is the 505 (b) is through repurposing GW Pharma’s Epidiolex which is an aerosolized oro-muscosal spray. Guess a guess. www.receptorlife.com/receptor-life-sciences-receives-fda-guidance-for-development-of-rls-103Will RLS run into the same problem LQDA is having. GWPH owns Epidiolex [1/11/21 GW Pharmaceuticals provides upbeat total and Epidiolex sales] will GWPH screw RLS by trying to convert it into a Technosphere product? The UTHR v LQDA is scaring the shit out of me.
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Post by mango on Jan 12, 2021 11:38:17 GMT -5
✅ Receptor Life Sciences wild card in play ✅ The meeting resulted in clear guidance on the regulatory requirements for the development and approval of RLS103 under section 505(b)(2) ✅ RLS103 is an investigational inhaled cannabidiol (CBD) designed for the treatment of acute panic attack ✅ Currently no immediate-acting products are available for panic attacks, so RLS103 has the potential to be First-in-Class ✅ Receptor will be utilizing MannKind’s Technosphere technology and inhalers ✅ RLS103 is a drug-device combination product based on the Technosphere® dry powder inhalation system licensed from MannKind Corporation ✅ This will be HUGE ————————————— My guess is the 505 (b) is through repurposing GW Pharma’s Epidiolex which is an aerosolized oro-muscosal spray. Guess a guess. www.receptorlife.com/receptor-life-sciences-receives-fda-guidance-for-development-of-rls-103Will RLS run into the same problem LQDA is having. GWPH owns Epidiolex [1/11/21 GW Pharmaceuticals provides upbeat total and Epidiolex sales] will GWPH screw RLS by trying to convert it into a Technosphere product? The UTHR v LQDA is scaring the shit out of me. I don’t see how GW Pharma has a case here. Epidiolex is a liquid formulation in a canister and is an aerosolized, oro-mucosal spray. Cannabidiol Technosphere will be a drug-device combination utilizing MannKind’s patent protected dry powder formulation and inhalation device technologies. There’s no way patent infringement is at play here. I’m also just guessing about Epidiolex because I can’t think of any other FDA CBD approved product on the market that we can repurpose that suits the 505(b)2 pathway. Maybe it’s something else I’ve never heard of?
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Post by Deleted on Jan 12, 2021 11:40:25 GMT -5
Will RLS run into the same problem LQDA is having. GWPH owns Epidiolex [1/11/21 GW Pharmaceuticals provides upbeat total and Epidiolex sales] will GWPH screw RLS by trying to convert it into a Technosphere product? The UTHR v LQDA is scaring the shit out of me. I don’t see how GW Pharma has a case here. Epidiolex is a liquid formulation in a canister and is an aerosolized, oro-mucosal spray. Cannabidiol Technosphere will be a drug-decide combination utilizing MannKind’s patent protected dry powder formulation and inhalation device technologies. There’s no way patent infringement is at play here. LQDA probably thought the same thing and look what UTHR is doing to them.
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Post by goyocafe on Jan 12, 2021 11:41:07 GMT -5
Will RLS run into the same problem LQDA is having. GWPH owns Epidiolex [1/11/21 GW Pharmaceuticals provides upbeat total and Epidiolex sales] will GWPH screw RLS by trying to convert it into a Technosphere product? The UTHR v LQDA is scaring the shit out of me. I don’t see how GW Pharma has a case here. Epidiolex is a liquid formulation in a canister and is an aerosolized, oro-mucosal spray. Cannabidiol Technosphere will be a drug-decide combination utilizing MannKind’s patent protected dry powder formulation and inhalation device technologies. There’s no way patent infringement is at play here. I’m also just guessing about Epidiolex because I can’t think of any other FDA CBD approved product on the market that we can repurpose that suits the 505(b)2 pathway. Maybe it’s something else I’ve never heard of? Well, if GW Pharma wants to license Technosphere from Mannkind, I wouldn’t have a problem with that.
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Post by mango on Jan 12, 2021 11:41:11 GMT -5
I don’t see how GW Pharma has a case here. Epidiolex is a liquid formulation in a canister and is an aerosolized, oro-mucosal spray. Cannabidiol Technosphere will be a drug-decide combination utilizing MannKind’s patent protected dry powder formulation and inhalation device technologies. There’s no way patent infringement is at play here. LQDA probably thought the same thing and look what UTHR is doing to them. Nope. Two totally different things. One is liquid canister and the other is dry powder inhaler.
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Post by mango on Jan 12, 2021 11:44:03 GMT -5
Let’s also not forget the the CEO of RLS is a an expert in Cannabis and patent law, and is partner at a prestigious law firm who has an an entire team dedicated to patents and Cannabis law.
I think we’re in good hands. 😊
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Post by mango on Jan 12, 2021 12:46:33 GMT -5
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Post by Deleted on Jan 12, 2021 15:28:19 GMT -5
I don’t see how GW Pharma has a case here. Epidiolex is a liquid formulation in a canister and is an aerosolized, oro-mucosal spray. Cannabidiol Technosphere will be a drug-decide combination utilizing MannKind’s patent protected dry powder formulation and inhalation device technologies. There’s no way patent infringement is at play here. I’m also just guessing about Epidiolex because I can’t think of any other FDA CBD approved product on the market that we can repurpose that suits the 505(b)2 pathway. Maybe it’s something else I’ve never heard of? Well, if GW Pharma wants to license Technosphere from Mannkind, I wouldn’t have a problem with that. That's the problem....You have RLS licensing TS for Epidiolex and GW owns patents. You will not have RLS and GW licensing for the same drug.
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Post by mango on Jan 12, 2021 21:26:29 GMT -5
Well, if GW Pharma wants to license Technosphere from Mannkind, I wouldn’t have a problem with that. That's the problem....You have RLS licensing TS for Epidiolex and GW owns patents. You will not have RLS and GW licensing for the same drug. The Chief Medical Advisor for RLS is Orrin Devinsky. Dr. Devinsky served as a principal investigator for the development of GW Pharmaceuticals' Epidiolex® (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. I believe calling the attention of GW will be a good thing. They may want in. GW has lots going on besides Epidiolex. I read a GW slide once and think I remember it having something about an improved *inhaled* version and pill versions of different cannabinoid therapeutics. Two things MannKind and RLS are focusing on. I wonder how much cash GW has on hand right now?
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Post by akemp3000 on Jan 13, 2021 5:21:12 GMT -5
Excellent posts and information mango!
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Post by neil36 on Jan 13, 2021 7:10:53 GMT -5
I just re-read this quote from a 2018 news article when RLS raised $29 million:
“Wesner commented, “The closing of the Series A round will allow us to initiate IND-enabling studies in the United States and to formalize collaborations in Canada and Europe. The growing consensus is that cannabinoids have the potential to meet numerous and significant unmet medical needs for indications including epilepsy, chronic pain and post-traumatic stress disorder. By leveraging validated drug delivery technologies, we believe our products have the potential to set the standard of care for cannabinoid medicines in terms of onset of action, bioavailability and consistency.””
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Post by mango on Jan 13, 2021 9:10:00 GMT -5
We will garner the attention of every big and small player in the cannabinoid pharmaceutical space once Technosphere Cannabidiol/RLS103 initiates Phase 1.
More partnerships on the horizon?
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Post by mango on Jan 13, 2021 9:15:04 GMT -5
I suspect RLS is partner shopping right now for funding through approval, commercialization and marketing.
No way they can afford this on their own unless they do an IPO.
Who will it be?
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