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Post by gwb on Sept 9, 2018 12:34:21 GMT -5
The problem is there is no definition of food effect on the slide. I believe it to mean as as ryster stated, "It DOES effect appetite, just that food does NOT effect how the compound is absorbed through the body as it is dosed via pulmonary route and not stomach.." The global market for dronabinol was $160 million in 2016 and is expected to grow dramatically based on increased drug availability, a change in public opinion toward medical cannabis, new methods of drug delivery and the results from new clinical trials, as reported by Zacks Small-Cap Research. According to Insys Therapeutics, the current annual market for dronabinol is approximately 280,000 prescriptions with a potential addressable population of roughly 800,000 in CINV and 90,000 in AIDS anorexia.
globenewswire.com/news-release/2018/05/15/1502640/0/en/AXIM-Biotechnologies-Advances-Dronabinol-Therapeutic-Equivalence-Program-Through-Purchase-Agreement-With-Noramco.htmlNEW YORK, May 15, 2018 (GLOBE NEWSWIRE) -- AXIM® Biotechnologies, Inc. (AXIM) (OTC:AXIM), a world leader in cannabinoid research and development, today announced that it has reached a long-term purchase agreement for pharmaceutical-grade dronabinol with Noramco, a global leader in the production of controlled substances for the pharmaceutical industry. The agreement outlines an initial purchase of the Active Pharmaceutical Ingredient (API) dronabinol, which is a synthetic form of tetrahydrocannabinol (THC), to be used in AXIM’s clinical trials for treatment of chemotherapy-induced nausea/vomiting (CINV) and anorexia associated with weight loss in patients with cancer or AIDS. AXIM will microencapsulate the API and formulate it into its proprietary controlled-release chewing gum delivery system, which will go through an open-label clinical study comparing the bioavailability and therapeutic equivalence of the Company’s product to the FDA-approved reference listed drug (RLD) Marinol®. “This relationship marks a pivotal and important milestone for the dronabinol program,” said George E. Anastassov, MD, DDS, MBA and Chief Executive Officer of AXIM. “Partnering with such a well-known supplier will enable us to not only move forward with this clinical trial but make the move to sustained production when we receive approval.” In its current form, Marinol is delivered through a gel capsule where almost all of the dronabinol is metabolized into 11-OH-THC due to the first-pass (liver) metabolism. According to AXIM’s researchers, this may cause significant undesirable side effects for patients including impaired thinking and other adverse reactions. AXIM’s patented controlled-release chewing gum will be designed to largely bypass the first-pass metabolism in the liver with the goal of decreasing side effects for patients. AXIM recently announced the completion of a pre-IND meeting with the Food and Drug Administration (FDA) regarding the therapeutic equivalence study and has received the green light for IND submission to the FDA. The study, which can be found on ClinicalTrials.gov, is a two-part, open-label, randomized cross-over study and will enroll 50 patients aged between 18 and 55 years of age. The study will compare the bioavailability of the two different dronabinol formulations and is expected to start soon. The global market for dronabinol was $160 million in 2016 and is expected to grow dramatically based on increased drug availability, a change in public opinion toward medical cannabis, new methods of drug delivery and the results from new clinical trials, as reported by Zacks Small-Cap Research. According to Insys Therapeutics, the current annual market for dronabinol is approximately 280,000 prescriptions with a potential addressable population of roughly 800,000 in CINV and 90,000 in AIDS anorexia.
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Post by mnholdem on Sept 12, 2018 19:58:21 GMT -5
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Post by babaoriley on Sept 13, 2018 12:31:53 GMT -5
GWB, WTF? Lost sheep finds herd?
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Post by patten1962 on Oct 5, 2018 7:33:33 GMT -5
Receptor Life Sciences is such an enigma. I was wondering last night: Does anyone see a scenario where United therapeutics buys receptor life sciences?
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Post by peppy on Oct 5, 2018 8:07:53 GMT -5
Receptor Life Sciences is such an enigma. I was wondering last night: Does anyone see a scenario where United therapeutics buys receptor life sciences?
Regarding RLS, I do not. see a UTHR synergy. So far the word is receptor working on a MARINOL type competitor. So an antiemetic. it would seem they want to establish some standard for dosages. (?) (perhaps get it approved?) there is a slide. scroll up. United therapeutics and receptor life. I do not see where CBD/THC would work. Sounds/looks like scar tissue builds up and the vessel looses it's elasticity? This is showing inflammatory cells in the vascular smooth muscle. probably showing the mechanism? These cells, macrophage, eosinophils, releasing toxins into the pulmonary vascular smooth muscle? something to think about now that you mention it.
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Post by patten1962 on Oct 5, 2018 8:14:01 GMT -5
Receptor Life Sciences is such an enigma. I was wondering last night: Does anyone see a scenario where United therapeutics buys receptor life sciences?
Regarding RLS, I do not. see a UTHR synergy. So far the word is receptor working on a MARINOL type competitor. So an antiemetic. it would seem they want to establish some standard for dosages. (?) (perhaps get it approved?) there is a slide. scroll up. United therapeutics and receptor life. I do not see where CBD/THC would work. Sounds/looks like scar tissue builds up and the vessel looses it's elasticity? This is showing inflammatory cells in the vascular smooth muscle. probably showing the mechanism? These cells, macrophage, eosinophils, releasing toxins into the pulmonary vascular smooth muscle? something to think about now that you mention it. Thank you
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Post by sayhey24 on Oct 8, 2018 18:42:07 GMT -5
The big day in Canada is next week October 17th. It will be interesting to see if we hear anything from RLS soon after.
Last weeks filing had that familiar name in it Arthur Rubinfeld. A former Microsoft consultant who helped build the Starbucks brand and friend of Kevin Johnson.
Is Starbucks getting into the pot business in Canada is the $Billion question. SecondCup has already announced they will be dedicating some stores to pot. The pressure on Starbucks is clearly on.
IMO Technosphere Pot would be a game changer. Its clean, classy, predosed and lung healthy. Mike said last week they are using the prefilled cricket for RLS and its "flying beautifully".
It sure would be nice to finally see the MNKD pps fly.
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Post by mnkdfann on Oct 8, 2018 19:11:28 GMT -5
The big day in Canada is next week October 17th. It will be interesting to see if we hear anything from RLS soon after. I was trying to figure out what you meant. Today was our big day, i.e. Thanksgiving. But I realise after a moment's thought you were talking legalization of pot. However, some prescription cannabis products are already available legally. And cannabis companies here and in the States have not been shy about announcing new products and ventures and deals in advance of the 17th. So I'm not sure why RLS would be waiting if it has something it wants to announce. Actually, though, I see no reason why it would want to announce anything unless it is tied in with an IPO. Why waste the ammo? FWIW, even after the 17th, cannabis vape pens and concentrates and edibles will still be illegal in Canada for some significant additional lengths of time. I don't know what the RLS products will look like, but I suspect they will not yet be allowed in Canada under the new legislation. They may have to wait for phase 2.
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Post by sayhey24 on Oct 8, 2018 19:27:41 GMT -5
Mike said last week they are using the single use inhaler so they will look like one of this page www.mannkindcorp.com/research-development/tech-platforms/oral-inhalers/How they get packaged we would need to ask Arthur, the guy who figured out how to get people to pay $10 for a coffee and donut and stand in line to do it. My guess; individual inhaler; 6 pack; carton. Why do you think the new legislation would stop them? I thought the opposite but have not read C-45 in detail. I thought the big thing for Starbuck's is it opens up banking. Canada also has more Starbucks per capita than any other country.
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Post by mnkdfann on Oct 8, 2018 19:35:25 GMT -5
The big day in Canada is next week October 17th. It will be interesting to see if we hear anything from RLS soon after. Last weeks filing had that familiar name in it Arthur Rubinfeld. A former Microsoft consultant who helped build the Starbucks brand and friend of Kevin Johnson. Is Starbucks getting into the pot business in Canada is the $Billion question. SecondCup has already announced they will be dedicating some stores to pot. The pressure on Starbucks is clearly on. IMO Technosphere Pot would be a game changer. Its clean, classy, predosed and lung healthy. Mike said last week they are using the prefilled cricket for RLS and its "flying beautifully". It sure would be nice to finally see the MNKD pps fly. Second Cup is a failing business. It was nearly shuttered a year or two ago. In 2017, the chain had a net income of $110,000. I love Second Cup (I like it more than Starbucks), but it is not doing good. It's announcement about pot may be nothing more than a Hail Mary pass. Pressure on Starbucks? IMO, not really. While Second Cup's announcement back in April did give the company's share price a lift, it did not last. AFAIK, Second Cup does not have a license to do this (open recreational pot shops) anyway. And I think it is doubtful that any cities would permit more than a handful of stores. It seems most major municipalities in Canada are doing what they can to really limit availability of pot retail outlets. Canadian cities are not turning into Amsterdam clones anytime soon. www.theglobeandmail.com/business/article-second-cup-eyes-converting-some-coffee-shops-into-marijuana-stores/www.newswire.ca/news-releases/national-access-cannabis-and-second-cup-announce-updated-plans-to-build-retail-meta-stores-across-ontario-690957331.html
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Post by mango on Oct 8, 2018 19:39:04 GMT -5
We also have the Cannabinoid class [ph], so this is a hot space today. But we were in it three years ago before anybody else even really thought about this with a partner called Receptor Life Sciences. And so this is something that people somewhat forgot about the company has been working along the line behind the scenes, they've taken powders, they've formulated them, and we know we can take the tree sap of the leaves and make them into dry powder inhalations that work quite beautifully. So that's something we expect to continue here more with receptor life sciences in the cannabinoid space.
Tree sap of the leaves.......works quite beautifully......must have taken a puff of "tree sap of the leaves" before this conference uh huh. 😄🧐
If they are using whole plant Cannabis extract instead of synthetic compound dronabinol, then even better. Sounds like that is the case here unless of course Mike was just (((high))) on tree sap
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Post by mnkdfann on Oct 8, 2018 19:41:09 GMT -5
Why do you think the new legislation would stop them? I thought the opposite but have not read C-45 in detail. I thought the big thing for Starbuck's is it opens up banking. Canada also has more Starbucks per capita than any other country. As I said, the new legislation does not allow many forms of cannabis to be sold. No edibles, no concentrates, no vapers, etc. What is being allowed is very limited. Canadians will be permitted to: purchase fresh or dried cannabis, cannabis oil, plants and seeds for cultivation from either a provincially or territorially regulated retailer, or — where that option is not available — directly from a federally licensed producer; possess up to 30 grams of dried legal cannabis or its equivalent in public; share up to 30 grams (or its equivalent) of legal cannabis and legal cannabis products with other adults; cultivate up to four plants at home (four plants total per household); and prepare various cannabis products (such as edibles) at home for personal use, provided that no dangerous organic solvents are used in the process. We are NOT free to use it anywhere we like. In most municipalities, there will be no public use allowed.
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Post by sayhey24 on Oct 8, 2018 19:55:19 GMT -5
My understanding is the local provinces are handling the licensing. I think part of the fear is seeing dispensaries like in the States.
A clean, commercial product in a box eliminates everything bad which come with the dispensaries. A prefilled product in a box can be sold from the shelf next to the blueberry scone. There is no need to dedicate the entire store.
The SecondCup model I think is the dispensary model where the entire store is dedicated.
What I do know is Arthur Rubinfeld left a multimillion $ job at Starbucks for RLS. I also know Starbucks would be the perfect venue and Canada has a bunch of Starbucks. I also know Mike brought up RLS last week and Mike usually drops a hint before things get announced.
What I also know is MNKD needs a break and RLS could be that thing which pops the pps. Hope springs eternal but RLS could very well be reality, we will see.
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Post by sayhey24 on Oct 8, 2018 20:35:16 GMT -5
Here is the bill www.parl.ca/DocumentViewer/en/42-1/bill/C-45/royal-assentIt looks like schedule 4 was amended 193.1 Schedule 4 to the Cannabis Act is amended by adding the following in numerical order: Item edibles containing cannabis and cannabis concentrates. The bill also permits vaporizers. Dried cannabis was already permitted under schedule 4. Is TS pot dried cannabis or a concentrate, maybe its a dried concentrate but both are allowed now. Maybe RLS was waiting on a ruling but it appears IMO C-45 permits it?
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Post by mango on Oct 8, 2018 20:43:32 GMT -5
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