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Post by madog365 on Nov 7, 2017 23:19:19 GMT -5
Their trademark applications were declined and the business registration with washington state expires at the end of this year. Would anyone be surprised if they don't renew and switch names and keep it completely quiet this time? They obviously do not want to be discussed. After i made this post i thought i would look into the registration for RLS in washington, and after clicking around to see if any new companies were registered by the same governing persons recently i stumbled upon this one which does feature Mr.Wesner as a governing person. Anyways i won't spoil the surprise but go ahead and look who the other person is. Let's just say they don't exist anywhere on google search. www.sos.wa.gov/corps/search_detail.aspx?ubi=604183080The question is, are they messing with us?
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Post by mango on Nov 7, 2017 23:22:40 GMT -5
MNKD and RLS are kindred spirits... progress is so very slow but it is progress and overtime it makes sense. Someday it will make cents too.. Assuming RLS is making any progress is merely an assumption. In reality we have no visibility. Likewise though it could be fast, merely slow or any other speed... we just don't know. All we know is it hasn't triggered any additional payments to MNKD, but from leaked presentation we've seen the inhaled cannabis wasn't the first product they intended to commercialize. Technically, they have received additional payments from RLS: Recognized revenue related to this license agreement amounted to $0.1 million and $0.2 for the three and nine months ended September 30, 2017.Also something noteworthy is the fact that MannKind has mentioned several times in their SEC filings that Receptor also has sublicensees which they will also be entitled to receive royalties from: Royalties upon Receptor’s and its sublicensees’ sale of the productI'm not sure if what RLS is doing is going to necessarily be whole plant Cannabis extract. It just is not plausible to develop and manufacture a dry powder cannabinoid medicine from whole plant Cannabis extract. There is simply no feasible way anyone can reproduce the same exact product over and over to supply even just this country because the amount of raw Cannabis material that would be required to be grown in an controlled environment would have to be millions and millions of square feet. Maybe even the size of an entire state. Also, the purification process is extremely timely and costly, not to mention difficult—all of which would require a manufacturing facility that meets the FDA's CGMPs. Few things come to my mind: 1) The body's own naturally occuring cannabinoids, the endocannabinoids and endocannabinoid-like compounds, can be developed to mimic their action and bind to specific cannabinoid and cannabinoid-like receptor sites. 2) Biosynthethic cannabinoid production—just like how rDNA insulin is made, similar methods with yeast and E. coli can be used to produce every single known cannabinoid, all of which would be structurally identical to natural occuring cannabinoids found in the Cannabis plant. 3) Supposedly Receptor identified specific compounds of which MannKind performed the inital formulation studies on. This means whatever these compounds are, they are not derived from whole plant Cannabis extract because that would not be proprietary. We were specifically told that the compounds identified by Receptor are proprietary.
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Post by mango on Nov 7, 2017 23:25:02 GMT -5
Their trademark applications were declined and the business registration with washington state expires at the end of this year. Would anyone be surprised if they don't renew and switch names and keep it completely quiet this time? They obviously do not want to be discussed. After i made this post i thought i would look into the registration for RLS in washington, and after clicking around to see if any new companies were registered by the same governing persons recently i stumbled upon this one which does feature Mr.Wesner as a governing person. Anyways i won't spoil the surprise but go ahead and look who the other person is. Let's just say they don't exist anywhere on google search. www.sos.wa.gov/corps/search_detail.aspx?ubi=604183080The question is, are they messing with us? Lol Plot twist.
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RLS
Nov 8, 2017 0:10:22 GMT -5
Post by dreamboatcruise on Nov 8, 2017 0:10:22 GMT -5
Assuming RLS is making any progress is merely an assumption. In reality we have no visibility. Likewise though it could be fast, merely slow or any other speed... we just don't know. All we know is it hasn't triggered any additional payments to MNKD, but from leaked presentation we've seen the inhaled cannabis wasn't the first product they intended to commercialize. Technically, they have received additional payments from RLS: Recognized revenue related to this license agreement amounted to $0.1 million and $0.2 for the three and nine months ended September 30, 2017.Also something noteworthy is the fact that MannKind has mentioned several times in their SEC filings that Receptor also has sublicensees which they will also be entitled to receive royalties from: Royalties upon Receptor’s and its sublicensees’ sale of the productI'm not sure if what RLS is doing is going to necessarily be whole plant Cannabis extract. It just is not plausible to develop and manufacture a dry powder cannabinoid medicine from whole plant Cannabis extract. There is simply no feasible way anyone can reproduce the same exact product over and over to supply even just this country because the amount of raw Cannabis material that would be required to be grown in an controlled environment would have to be millions and millions of square feet. Maybe even the size of an entire state. Also, the purification process is extremely timely and costly, not to mention difficult—all of which would require a manufacturing facility that meets the FDA's CGMPs. Few things come to my mind: 1) The body's own naturally occuring cannabinoids, the endocannabinoids and endocannabinoid-like compounds, can be developed to mimic their action and bind to specific cannabinoid and cannabinoid-like receptor sites. 2) Biosynthethic cannabinoid production—just like how rDNA insulin is made, similar methods with yeast and E. coli can be used to produce every single known cannabinoid, all of which would be structurally identical to natural occuring cannabinoids found in the Cannabis plant. 3) Supposedly Receptor identified specific compounds of which MannKind performed the inital formulation studies on. This means whatever these compounds are, they are not derived from whole plant Cannabis extract because that would not be proprietary. We were specifically told that the compounds identified by Receptor are proprietary. Is that new revenue or simply recognizes deferred portions of part of the $1M received. However, either way, it's immaterial. If it's not a true milestone payment, it's simply reimbursing MNKD for some misc costs.
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RLS
Nov 8, 2017 5:06:08 GMT -5
via mobile
Post by victoria on Nov 8, 2017 5:06:08 GMT -5
After i made this post i thought i would look into the registration for RLS in washington, and after clicking around to see if any new companies were registered by the same governing persons recently i stumbled upon this one which does feature Mr.Wesner as a governing person. Anyways i won't spoil the surprise but go ahead and look who the other person is. Let's just say they don't exist anywhere on google search. www.sos.wa.gov/corps/search_detail.aspx?ubi=604183080The question is, are they messing with us? Lol Plot twist. Ajira seems to be a place in Tanzania. Wonder if thats relevant. And if I google Traci Carnab, google gives me Traci Carmen... Perceptive of it?
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RLS
Nov 8, 2017 8:57:14 GMT -5
Post by mnholdem on Nov 8, 2017 8:57:14 GMT -5
Their trademark applications were declined and the business registration with washington state expires at the end of this year. Would anyone be surprised if they don't renew and switch names and keep it completely quiet this time? They obviously do not want to be discussed. After i made this post i thought i would look into the registration for RLS in washington, and after clicking around to see if any new companies were registered by the same governing persons recently i stumbled upon this one which does feature Mr.Wesner as a governing person. Anyways i won't spoil the surprise but go ahead and look who the other person is. Let's just say they don't exist anywhere on google search. www.sos.wa.gov/corps/search_detail.aspx?ubi=604183080The question is, are they messing with us? They filed the company registration with Washington on Oct 20, 2017, but also filed a company registration in Delaware on Oct 2, 2017.
www.bizapedia.com/de/ajira-therapies-inc.html
The Delaware registration states the company's age is one month, so I suggest you consider that entrepreneurs often start up multiple companies. Ajira Therapeutics is likely not synonymous with Receptor Life Sciences, even if the same principals are involved.
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Post by madog365 on Nov 21, 2017 10:22:21 GMT -5
In the interview posted today, Mike Castagna finally confirms what RLS is working on. "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." The active ingredient of MARINOL Capsules is man-made dronabinol (dro-NAB-in-all), also chemically known as tetrahydrocannabinol, or THC. THC is also a naturally occurring component of marijuana. Marinol is sold by AbbVie. Looking at the 505(b) strategy mentioned it seems RLS will be using AbbVie's clinical trials data and already FDA approved drug to push for expedited approval of its own formulation which i assume utilizes this same synthetic THC drug with technosphere technology.
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RLS
Nov 21, 2017 10:55:14 GMT -5
Post by boca1girl on Nov 21, 2017 10:55:14 GMT -5
In the interview posted today, Mike Castagna finally confirms what RLS is working on. "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." The active ingredient of MARINOL Capsules is man-made dronabinol (dro-NAB-in-all), also chemically known as tetrahydrocannabinol, or THC. THC is also a naturally occurring component of marijuana. Marinol is sold by AbbVie. Looking at the 505(b) strategy mentioned it seems RLS will be using AbbVie's clinical trials data and already FDA approved drug to push for expedited approval of its own formulation which i assume utilizes this same synthetic THC drug with technosphere technology.
Would they owe a royalty or any payment to AbbVie? Or does the 505(b) mean it is “free” to use?
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Post by mnholdem on Nov 21, 2017 11:08:15 GMT -5
The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”) drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant.
A 505(b)(2) NDA contains full safety and effectiveness reports but allows at least some of the information required for NDA approval, such as safety and efficacy information on the active ingredient, to come from studies not conducted by or for the applicant. This can result in a much less expensive and much faster route to approval, compared with a traditional development path [such as 505(b)(1)], while creating new, differentiated products with tremendous commercial value.
A company may wish to create a new dosage form that is faster acting, combines two active ingredients in a novel way, or provides a route of administration or mechanism of drug delivery that patients or doctors prefer over previous versions. Also, a company may wish to seek approval for a new indication for an already-approved drug or carry out an Rx-to-OTC switch. Such new products often contain well-understood active ingredients that are present in existing, approved drug products (reference drugs); so, companies must only create a bridge between what is already known about the previously approved reference drug and the novel drug product or indication. The 505(b)(2) NDA pathway makes this possible.
Source: camargopharma.com/what-is-505b2/
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RLS
Nov 21, 2017 11:08:21 GMT -5
liane and kc like this
Post by boca1girl on Nov 21, 2017 11:08:21 GMT -5
In the interview posted today, Mike Castagna finally confirms what RLS is working on. "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." The active ingredient of MARINOL Capsules is man-made dronabinol (dro-NAB-in-all), also chemically known as tetrahydrocannabinol, or THC. THC is also a naturally occurring component of marijuana. Marinol is sold by AbbVie. Looking at the 505(b) strategy mentioned it seems RLS will be using AbbVie's clinical trials data and already FDA approved drug to push for expedited approval of its own formulation which i assume utilizes this same synthetic THC drug with technosphere technology.
Would they owe a royalty or any payment to AbbVie? Or does the 505(b) mean it is “free” to use? An Increasing Number of Companies Are Using a Once-Obscure FDA Drug Approval Pathway Posted 08 April 2015 By Alexander Gaffney, RAC Companies are increasingly using a lesser-known regulatory pathway to get new doses, formulations or combinations of drugs approved by the US Food and Drug Administration (FDA), a review by Thompson Reuters has found. Background In the US, pharmaceutical products are in general approved in one of three ways: A drug never before approved by FDA for a specific condition is approved using a New Drug Application (NDA) through the 505(b)(1) pathway A generic drug referencing an already-approved NDA is approved using an Abbreviated New Drug Application (ANDA) through the 505(j) pathway An over-the-counter (OTC) drug is approved by referencing an existing monograph These three pathways collectively account for most of the products on the market. There are, however, several other pathways by which a drug can obtain approval. One of the most popular of those alternative pathways is the 505(b)(2) pathway, which is designed to allow the approval of a drug which isn't new, but differs in several meaningful aspects. As described in FDA's 1999 guidance document, Applications Covered by Section 505(b)(2), a 505(b)(2) application: " s one for which one or more of the investigations relied upon by the applicant for approval 'were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted.'"
In plain terms, the 505(b)(2) sponsor is relying upon clinical data or literature produced by other companies or entities.
But why would a company want to rely on that data? The most common reason is that the 505(b)(2) sponsor has made "changes to previously approved drugs," including its recommended dose, its formulation, its route of administration, its strength, or the drugs with which it is combined.
The 505(b)(2) pathway was created with the intent "to encourage innovation without creating duplicate work and reflects the same principle as the 505(j) application: it is wasteful and unnecessary to carry out studies to demonstrate what is already known about a drug," FDA explained in its guidance.
For example, if a company were to reformulate a drug such that it could be taken just once per day instead of three times per day, it could use the 505(b)(2) pathway to minimize the amount of original data it would need to submit in support of its new drug. Regulators could instead rely upon existing data showing that the reference drug is safe and effective, and focus on determining whether the changes made to the new drug alter its safety or efficacy.
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RLS
Nov 21, 2017 11:37:44 GMT -5
Post by goyocafe on Nov 21, 2017 11:37:44 GMT -5
Why Marinol? The symptoms this drug seems to address don't seem acute enough to suggest pulmonary delivery would create any real advantage over the existing pill.
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Post by madog365 on Nov 21, 2017 11:45:06 GMT -5
Why Marinol? The symptoms this drug seems to address don't seem acute enough to suggest pulmonary delivery would create any real advantage over the existing pill. Oh but to the contrary! "Compared with other oral medications, dronabinol takes effect quite slowly. Absorption through the gastrointestinal tract is inherently slow; however, a typical over-the-counter pain reliever achieves results within 30 minutes, while dronabinol's peak activity does not occur until two to four hours after ingestion. This is not the case when dronabinol is injected or inhaled. Delivered by these methods, the drug reaches its maximum level in the body nearly instantaneously because it enters the bloodstream immediately (inhaled dronabinol is absorbed directly into capillaries in the lungs). While peak dronabinol concentrations may vary greatly among patients who take it orally, inhalation and injection produce more consistent levels of the drug." There's a reason it's not used to treat pain today. "Pharmaceutical companies must also get approval from the FDA before marketing an approved drug in a new dosage form. For example, if Unimed Pharmaceuticals, the manufacturer of Marinol, wanted to produce an inhaled version of the medicine, it would first have to conduct research to prove that the new delivery method is safe and effective." Technosphere is already FDA approved delivery method. I encourage you to read more about Marinol here; www.ncbi.nlm.nih.gov/books/NBK224399/
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Post by goyocafe on Nov 21, 2017 11:53:07 GMT -5
Why Marinol? The symptoms this drug seems to address don't seem acute enough to suggest pulmonary delivery would create any real advantage over the existing pill. Oh but to the contrary! "Compared with other oral medications, dronabinol takes effect quite slowly. Absorption through the gastrointestinal tract is inherently slow; however, a typical over-the-counter pain reliever achieves results within 30 minutes, while dronabinol's peak activity does not occur until two to four hours after ingestion. This is not the case when dronabinol is injected or inhaled. Delivered by these methods, the drug reaches its maximum level in the body nearly instantaneously because it enters the bloodstream immediately (inhaled dronabinol is absorbed directly into capillaries in the lungs). While peak dronabinol concentrations may vary greatly among patients who take it orally, inhalation and injection produce more consistent levels of the drug." There's a reason it's not used to treat pain today. "Pharmaceutical companies must also get approval from the FDA before marketing an approved drug in a new dosage form. For example, if Unimed Pharmaceuticals, the manufacturer of Marinol, wanted to produce an inhaled version of the medicine, it would first have to conduct research to prove that the new delivery method is safe and effective." Technosphere is already FDA approved delivery method. I encourage you to read more about Marinol here; www.ncbi.nlm.nih.gov/books/NBK224399/Much appreciated. I didn't gather any of this from the official web site for the drug. Very interesting. Thank you.
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Post by madog365 on Nov 21, 2017 12:08:53 GMT -5
Oh but to the contrary! "Compared with other oral medications, dronabinol takes effect quite slowly. Absorption through the gastrointestinal tract is inherently slow; however, a typical over-the-counter pain reliever achieves results within 30 minutes, while dronabinol's peak activity does not occur until two to four hours after ingestion. This is not the case when dronabinol is injected or inhaled. Delivered by these methods, the drug reaches its maximum level in the body nearly instantaneously because it enters the bloodstream immediately (inhaled dronabinol is absorbed directly into capillaries in the lungs). While peak dronabinol concentrations may vary greatly among patients who take it orally, inhalation and injection produce more consistent levels of the drug." There's a reason it's not used to treat pain today. "Pharmaceutical companies must also get approval from the FDA before marketing an approved drug in a new dosage form. For example, if Unimed Pharmaceuticals, the manufacturer of Marinol, wanted to produce an inhaled version of the medicine, it would first have to conduct research to prove that the new delivery method is safe and effective." Technosphere is already FDA approved delivery method. I encourage you to read more about Marinol here; www.ncbi.nlm.nih.gov/books/NBK224399/Much appreciated. I didn't gather any of this from the official web site for the drug. Very interesting. Thank you. No problem. This was snuck into the interview but in my mind is one of the most significant pieces of news we have received recently that has potential to impact the value of Mannkind as a company. When i first invested in Mannkind, i knew Afrezza was the focus but i was most excited as to how they would leverage their approved platform to go into pain management. Al mentioned this market so many times. We still don't know who is behind RLS but the fact that Mike was finally able to shed some light on what they are working on, it leads me to believe that they may be thinking about going public with their plans soon. Any information about who is funding this company could be a big time catalyst for Mannkind.
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RLS
Nov 21, 2017 12:22:57 GMT -5
via mobile
Post by mango on Nov 21, 2017 12:22:57 GMT -5
In the interview posted today, Mike Castagna finally confirms what RLS is working on. "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." The active ingredient of MARINOL Capsules is man-made dronabinol (dro-NAB-in-all), also chemically known as tetrahydrocannabinol, or THC. THC is also a naturally occurring component of marijuana. Marinol is sold by AbbVie. Looking at the 505(b) strategy mentioned it seems RLS will be using AbbVie's clinical trials data and already FDA approved drug to push for expedited approval of its own formulation which i assume utilizes this same synthetic THC drug with technosphere technology.
Can you post the interview please? I haven't seen it... Marinol is synthetic THC. Nothing wrong with that, but Marinol is a crappy drug...for numerous reasons. In the recent MannKind patent they use Cannabis extract, not synthetic THC. I wonder which route will be taken...synthetic or whole plant extract? Unfortunately, it has been scientifically proven that the Entourage Effect, which is only something that can occur within the body through utilizing natural whole plant Cannabis which work in synchrony via the major and minor cannabinoids, terpenes, and flavonoids, etc. With Marinol, there is only a synthetic THC compound so there is loss of essential synergy. The reason why this is so important is because the body and the cannabinoids, terpenes and flavonoids all work in harmony, in sychrony, utilizing the body's natural metabolic pathways involved in homeostasis and health—they are all required to activate and/or inhibit specific actions—not forcing unnatural metabolic responses which causes harm and undesirable side effecta (which is seen in most of the medicines available today). Since MannKind/RLS's formulation will obviously be superior to the current available therapy, I have to wonder if they will be utilizing whole plant Cannabis extract instead of synthetic THC. Perhaps biosynthetic cannabinoids are an option as well (utilizing bacteria or yeast like with insulin). Marinol is currently used in people with AIDS to help with appetite, and for nausea and vomiting in cancer chemotherapy patients. These are definitely unmet needs and these people would benefit tremendously from a cannabinoid medicine that is safe and effective and reliable and affordable—from a company that cares about their wellbeing. Also, from MannKind's patent they tested their formulation using Cannabis extract and also tested CBD. Marinol does not use CBD nir does it use Cannabis extract. It is also in an encapsulated pill. This prevents the patient from receiving immediate relief and also does not avoid first pass. Utilizing Technosphere cannabinoid based therapeutics, this formulation could prove to be extremely benefiticial for people's physicial and mental health. It might even be cost friendlier. CBD is non-intoxicating (non-psychoactive is incorrect). It also is an allosteric modulator. It has weak binding affinity for CB1 and CB2 receptors, but works in concert with the many cannabinods—an essential component of the Entourage Effect. It also works through numerous non-cannabinoid receptors and also activates ion channels. It actually can increase endogenous cannabinoid levels (endocannabinoid tone), and because of this, CBD is also an Anandamide reuptake inhibitor. This is important because there is either a deficiency or over-production in endocannabinoid tone in every single unhealthy condition (there is a deficiency in many conditions). Endocannabinoids are produced on demand and used when needed. This is an endogenous system which regulates regulation. The phyto-cannabinoids just happen to mimic and activate essential pathways involved in maintaining health that our endocannabinoids would otherwise be involved in during normal healthy physiologic Because it is an allosteric modulator, with the right ratios of THC:CBD it can do two things: inhibit or enhance a receptors signaling transmission (for example—tone down the effect of THC or enhance the duration of its effects, etc). Having the ability to prolong the therapeutic window might prove be a something desirable for these patients. In high amounts CBD activates the 5-HT1A serotonin receptor. 5-HT1A is a G-coupled protein receptor. This receptor is a neurotransmitter and is involved in things like appetite, sleep, pain and nausea and vomiting. CBD also works through the peroxisome proliferator activated receptors. Here, it is an PPAR agonist—this is where it exerts some of its anti-cancer properties. Another advantage to using whole planet extract versus a single synthetic cannabinoid is because of beta-caryophyllene, a sesquiterpene found not only in the Cannabis plant but also in the essential oil of black pepper, basil, and numerous other herbs. It is not only 100% legal and consumed dialy by the American population, it has the government's seal of approval via GRAS. Beta-caryophyllene has a higher affinity for the CB2 receptor than THC, and is has major therapeutic potential for auto-immune and inflammatory conditions. Major cannabinoids besides THC, like CBD and beta-caryophyllene, are essential to a very effective, safe, and reliable cannabinoid medicine because of their many therapeutic properties which work in synchrony with one another (entourage effect)—something not attainable with a single synthetic cannabinoid drug like Marinol. Marinol is a drug that should be taken off the market and replaced with something of actual benefit and that utilizes the science of a company that understands what health is. MannKind is that company.
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