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RLS
Nov 21, 2017 12:36:09 GMT -5
Post by casualinvestor on Nov 21, 2017 12:36:09 GMT -5
But I assume that if they want to use the 505(b)(2) pathway, they are going to use Marinol and stick to the uses that drug is already approved for: AIDS wasting and chemo appetite loss (Mike: "looking at bringing out something going forward in that space for hopefully oncology is what I think the market focus is"). Also, it might get picked up for off-label in treating appetite loss and behavioral disturbances for Alzheimer's patients.
I read that Marisol is a $20 million/year drug, but it didn't really say which year
I'm more excited by Trepostinil, as I think it's closer:
Castagna: With Trepostinil -- we went to the FDA in June and we got phenomenal feedback on a very clear development pathway. So that's not that expensive and it's relatively straightforward. And what that means is that we'll be submitting our IND in January, and in the first six months of next year we'll be testing that. It will be our second drug ever put in patients. And sometime next year we'll know whether or not we have another molecule going forward into a larger phase 3 program.
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RLS
Nov 21, 2017 13:23:55 GMT -5
Post by mango on Nov 21, 2017 13:23:55 GMT -5
But I assume that if they want to use the 505(b)(2) pathway, they are going to use Marinol and stick to the uses that drug is already approved for: AIDS wasting and chemo appetite loss (Mike: "looking at bringing out something going forward in that space for hopefully oncology is what I think the market focus is"). Also, it might get picked up for off-label in treating appetite loss and behavioral disturbances for Alzheimer's patients. I read that Marisol is a $20 million/year drug, but it didn't really say which year I'm more excited by Trepostinil, as I think it's closer: Castagna: With Trepostinil -- we went to the FDA in June and we got phenomenal feedback on a very clear development pathway. So that's not that expensive and it's relatively straightforward. And what that means is that we'll be submitting our IND in January, and in the first six months of next year we'll be testing that. It will be our second drug ever put in patients. And sometime next year we'll know whether or not we have another molecule going forward into a larger phase 3 program. Marinol and Syndros both use dronabinol. They are both the same but have different formulations—Syndros is considered to have a greater risk of being altered and abused. Both are capsules and both are crappy drugs. GW Pharmaceuticals is about to potentially gain FDA approval for using Cannabis extract. That is gaining approval through the botanical route. The only proprietary technologies in Sativex and Epidiolex are what is in the formulations and the spray canister. They do not have a patent over the Cannabis plant. Utilizing the data via 505b can be done for both pathways—synthetic and whole plant Cannabis extract. Since MannKind's patent specifically uses Cannabis extract and not a synthetic derivative of THC, I am currently lead to think that RLS plans to use whole plant Cannabis extract. Marinol and Syndros (made by INSYS) are essentially the same things, both using dronabinol, just with different formulations. AIDS patients and patients undergoing cancer chemotherapy would be much better off using whole plant Cannabis attained via any reputable grower in the states where it is legal. Why? Because a pill with a synthetic THC compound is crap and vastly inferior and produces side effects that are not seen with whole plant use. Further, these drugs have shown to make situations far worse and are unreliable. If/when GW gains approval, their clinical trial data would be far more useful than the former. GW uses a device more inline with an inhaler, and their science is seriously very good and world-reknowned, their formulations have also been clinically proven to have extremely low potential for abuse, ESPECIALLY considering the fact that it utilizes a 1:1 THC and CBD ratio. This prevents the patient from becoming intoxicated by THC and lowers the potential for abuse even more since CBD is an allosteric modulator. Having CBD in the formulaion like this makes the product vastly more safe, effective, and reliable while reducing unwanted side-effects that are often associated with synthetic cannabinoid drugs. I hope MannKind does the right thing.
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Post by mango on Nov 21, 2017 14:10:13 GMT -5
We can officially acknowledge now that the RLS PDF was completely bunk. I hope whoever made it will refrain from any other attempts to create deception.
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RLS
Nov 21, 2017 14:13:26 GMT -5
via mobile
Post by sportsrancho on Nov 21, 2017 14:13:26 GMT -5
We can officially acknowledge now that the RLS PDF was completely bunk. I hope whoever made it will refrain from any other attempts to create deception. Yep:-)
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RLS
Nov 21, 2017 14:13:43 GMT -5
mango likes this
Post by mytakeonit on Nov 21, 2017 14:13:43 GMT -5
I figured it was bunk from the start ... new idea of inhaling cannabis? What?!!!
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RLS
Nov 21, 2017 14:50:22 GMT -5
via mobile
Post by mango on Nov 21, 2017 14:50:22 GMT -5
This 2017 review article covers the pill formulation, Marinol and the liquid formulation, Syndros. Both are crappy drugs and have not established any reasons for why a patient should use a synthetic THC compound versus whole plant. Synthetic THC is nothing like THC from the Cannabis plant, and the two are going to produce significantly different profiles in humans. Synthetic cannabinoids can be potentially dangerous and harmful and is what is seen in the crap referred to as "spice". Natural cannabinoids of the Cannabis plant have zero association with synthetic cannabinoids. MannKind and RLS will have to change the landscape if they want to ever see acceptance of synthetic cannabinoid medicines over th natural plant—especially in a legalized state. Currently, there is zero reason/incentive to use these synthetic cannabinoid drugs over the real thing, especially those living in a state where it is legal. The reasons are many, but a coupe are health insurance, cost, effectiveness, and side effects. Anyone can make or buy a whole plant Cannabis extract in liquid form to be administered orally like how Syndros is. The same can currently be applied to Marinol with capsules. This environment begs for change. RLS will have to show the medical community and the patients why their formulation should be used over natural Cannabis products and synthetics. Another formulation using dronabinol will not be good enough. A entirely new forumulation and device using whole plant extract will need to be done. And this is what MannKind used in their patent is what Receptor intended to do via their trademark. • Receptor Life Sciences Trademark Pharmaceutical preparations for human use for the treatment of pain, central nervous systems, metabolic disorders, gastrointestinal disorders, for use in side effects from chemotherapy; inhalers sold pre-filled with pharmaceutical preparations; namely, pharmaceutical preparations with plant extracts for the treatment of pain, central nervous systems, metabolic disorders, gastrointestinal disorders and for use in side effects from chemotherapy; plant extracts for pharmaceutical purposes• MannKind Patent Preparation of Dry Powder Comprising Microcrystalline FDKP Particles Containing Δ9-THC or CBD. Isolated FDKP microcrystalline particles prepared as in Example 1 were suspended in ethyl alcohol. An approximately 1-4 wt % solution of cannabis extract, primarily comprising either Δ9-THC or CBD • Review Article A review of oral cannabinoids and medical marijuana for the treatment of chemotherapy-induced nausea and vomiting: a focus on pharmacokinetic variability and pharmacodynamics
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RLS
Nov 21, 2017 15:14:35 GMT -5
Post by madog365 on Nov 21, 2017 15:14:35 GMT -5
I'm not following Mango, how was the RLS pdf "completely bunk"?
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RLS
Nov 21, 2017 15:23:00 GMT -5
Post by mango on Nov 21, 2017 15:23:00 GMT -5
I'm not following Mango, how was the RLS pdf "completely bunk"? Aside from the fact that MannKind has explained many times that their collaboration with Receptor is for inhaled therapeutics—not pills or liquid for drops like the PDF claimed. The PDF also claimed they were targeting the states where Cannabis was legalized, targeting both the medical and recreational markets. In the recent interview, Mike explains they are in the medical-cannabis market and going down a pathway which requires FDA approval—indicating zero intention of developing something for recreational purposes and also not something to be found at a Cannabis dispensary but something which would require a prescription and specifically mentions oncology, something the PDF did not come close to presenting. "A second part in the pipeline is a collaboration called Receptor Life Sciences. That market was focused on the cannabinoid medical-marijuana space, and they'll be looking at a strategy around the 505(b)s for an old product called Marinol. And really, looking at bringing out something going forward in that space for hopefully oncology is what I think the market focus is."
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Post by madog365 on Nov 21, 2017 15:49:15 GMT -5
I was going to post a lengthy response but i simply will just disagree with you. The PDF was most definitely spot on and was the first mention anywhere that receptor was involved with cannabinoid research as well as listing the correct leadership team behind the company.
Also Mike would only mention the collaboration in the elements that Mannkind is involved in (inhaled cannabinoids). I'm not sure how from one sentence you could extrapolate that RLS is in no capacity pursuing other elements of the marijuana industry. Why would Mike mention that?
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RLS
Nov 21, 2017 16:21:28 GMT -5
Post by mango on Nov 21, 2017 16:21:28 GMT -5
I was going to post a lengthy response but i simply will just disagree with you. The PDF was most definitely spot on and was the first mention anywhere that receptor was involved with cannabinoid research as well as listing the correct leadership team behind the company. Also Mike would only mention the collaboration in the elements that Mannkind is involved in (inhaled cannabinoids). I'm not sure how from one sentence you could extrapolate that RLS is in no capacity pursuing other elements of the marijuana industry. Why would Mike mention that? Nothing in that PDF suggests they are involved in cannabinoid research. It suggests they want to sell products to medical and recreational users. We know now they are focused on oncology, and anticipate to develop something that will compete with Marinol. That sounds like the opposite of creating a "pod" and selling it on the legal market. They are going through the FDA. In Receptor's trademarks they specifically state inhalers pre-filled with pharmaceutical preparations, namely plant extracts. Nothing about a tablet or liquid oral formulations or anything else. Pharmaceutical preparations for human use for the treatment of pain, central nervous systems, metabolic disorders, gastrointestinal disorders, for use in side effects from chemotherapy; inhalers sold pre-filled with pharmaceutical preparations; namely, pharmaceutical preparations with plant extracts for the treatment of pain, central nervous systems, metabolic disorders, gastrointestinal disorders and for use in side effects from chemotherapy; plant extracts for pharmaceutical purposes
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Post by peppy on Nov 21, 2017 16:37:09 GMT -5
agreed, no synthetic has been shown to do the equal. Israel team could not equal, they tried the isotope, etc. what can be accomplished here is dose control with technosphere. we know epilepsy can be controlled and nausea can be controlled. go RLS. for the treatment of pain, central nervous systems, metabolic disorders, gastrointestinal disorders and for use in side effects from chemotherapy; plant extracts for pharmaceutical purposes
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akil
Newbie
Posts: 21
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RLS
Nov 21, 2017 17:49:54 GMT -5
Post by akil on Nov 21, 2017 17:49:54 GMT -5
isotope? Maybe you meant some other word. Elements have isotopes. compounds don't.
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Post by sayhey24 on Nov 21, 2017 19:17:11 GMT -5
We can officially acknowledge now that the RLS PDF was completely bunk. I hope whoever made it will refrain from any other attempts to create deception. Mango - what was debunked? If I remember correctly it said RLS was using technosphere THC/CBD for medical and recreational purposes. Mike talked about potentially their first medical formulation. Each targeted use requires a different CBD/TCH formulation. Not having any inside knowledge but based on the players involved I always assumed the recreational products would be sold in Starbucks. "I'll take a Granda, a raspberry scone and a 4 pack of the 8u's." Also, my understanding was they would have more THC than CBD from the extraction process so the left over TCH made sense for the recreational product.
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Post by derek2 on Nov 21, 2017 19:58:08 GMT -5
I know for a fact that the PDF was on the RLS web server. If you shortened the URL, you were able to access the directory structure. Poor security settings, and no message to visitors that files were confidential / off limits. Along with the PDF were:
1. The "trees" background graphic in various sizes for PCs, phones, and tablets 2. A PDF with instructions for the game "Settlers of Cattan" (I'm not kidding)
Now, perhaps RLS changed their idea on what compound they would use for inhalation, but that PDF with the 3 cannabis products (tincture, pill, inhaled) was indeed on the server. I didn't share at the time, since mods asked for people to respect RLS's IP.
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RLS
Nov 21, 2017 20:11:13 GMT -5
via mobile
Post by mango on Nov 21, 2017 20:11:13 GMT -5
I know for a fact that the PDF was on the RLS web server. If you shortened the URL, you were able to access the directory structure. Poor security settings, and no message to visitors that files were confidential / off limits. Along with the PDF were: 1. The "trees" background graphic in various sizes for PCs, phones, and tablets 2. A PDF with instructions for the game "Settlers of Cattan" (I'm not kidding) Now, perhaps RLS changed their idea on what compound they would use for inhalation, but that PDF with the 3 cannabis products (tincture, pill, inhaled) was indeed on the server. I didn't share at the time, since mods asked for people to respect RLS's IP. Without proof, we cannot verify your claims. The URL itself was also not formatted correctly and the entire incident reaks of BS. Which turned out to be the case.
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