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Post by radgray68 on Jul 1, 2022 20:48:42 GMT -5
Hold up. Anybody think we may be able to go OTC with some of this cannabidiol? I understand probably not at first, but if perhaps we could..... I think I'd need a bigger calculator.
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Post by cretin11 on Jul 2, 2022 6:13:53 GMT -5
Hold up. Anybody think we may be able to go OTC with some of this cannabidiol? I understand probably not at first, but if perhaps we could..... I think I'd need a bigger calculator. Difficult to envision a scenario where we could get our price point competitive in OTC market. Such a low barrier to entry in the overcrowded CBD space.
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Post by sayhey24 on Jul 2, 2022 7:27:05 GMT -5
Hold up. Anybody think we may be able to go OTC with some of this cannabidiol? I understand probably not at first, but if perhaps we could..... I think I'd need a bigger calculator. At one point in time Kevin Johnson's buddy Arthur Rubinfeld left Starbucks and went to RLS to develop the recreational business. He is no longer there and RLS announced they are focusing on prescription formulas. RLS103 has potential blockbuster potential. Once RLS103 is approved and Mike figures out how to sell afrezza to the T2s then you can pull out the bigger calculator. In the meantime the smaller fish like Tyvaso DPI and then the kids afrezza will pay the bills.
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Post by markado on Jul 11, 2022 21:06:56 GMT -5
Hold up. Anybody think we may be able to go OTC with some of this cannabidiol? I understand probably not at first, but if perhaps we could..... I think I'd need a bigger calculator. At one point in time Kevin Johnson's buddy Arthur Rubinfeld left Starbucks and went to RLS to develop the recreational business. He is no longer there and RLS announced they are focusing on prescription formulas. RLS103 has potential blockbuster potential. Once RLS103 is approved and Mike figures out how to sell afrezza to the T2s then you can pull out the bigger calculator. In the meantime the smaller fish like Tyvaso DPI and then the kids afrezza will pay the bills. 80% of the lowest prescription strength can become the highest OTC dosage - 4% Lidocaine vs 5% as an example. The benefit to OTC is similar to Rx ... Controlled dose and consistent quality with a desired (calming) effect. It has merit, and in that it is not ingested and digested and its onset is rapid...all the more plus points. Easily licensed product, if RLS wants to focus on Rx only.
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Post by akemp3000 on Jul 12, 2022 5:37:36 GMT -5
Just saw this regarding another unrelated potential drug: "To move from prescription to OTC, drug makers must prove the drug can be used safely and effectively by consumers without supervision from a healthcare provider and must have a low potential for misuse and abuse". This of course is obvious. It sure seems like RLS has the potential to accomplish this and this could possibly be why Andrea Leone-Bay joined RLS. Maybe someone can provide better clarity regarding this challenge and potential. If ultra-rapid calming could be safely provided OTC, the potential would be nothing short of a Blockbuster.
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Post by cretin11 on Jul 12, 2022 7:55:27 GMT -5
The CBD product would seemingly be a slam dunk for OTC if RLS wants to go that route. The potential for misuse/abuse is extremely low, given the non-toxicity of CBD generally. However, IMO there’s not much blockbuster potential because of the already saturated market. Assuming price point will have to be at or higher than currently available CBD products, the rapid onset isn’t enough of a differentiator (for OTC market), because CBD tinctures already offer onset of effects within minutes.
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Post by slapshot on Jul 12, 2022 9:10:49 GMT -5
The CBD product would seemingly be a slam dunk for OTC if RLS wants to go that route. The potential for misuse/abuse is extremely low, given the non-toxicity of CBD generally. However, IMO there’s not much blockbuster potential because of the already saturated market. Assuming price point will have to be at or higher than currently available CBD products, the rapid onset isn’t enough of a differentiator (for OTC market), because CBD tinctures already offer onset of effects within minutes. i generally agree with you here, but in the famous (at least to baseball fans in the 80's) word of Joaquin Andujar, "youneverknow".
Ive used tinctures but not a fan and would try a dreamboat / ti in a heartbeat.
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Post by prcgorman2 on Jul 12, 2022 9:14:12 GMT -5
So refreshing to see a dialogue about RLS publishing material news about their development towards yet another potential Mannkind FDA-approved TS-enabled therapeutic. For years RLS has been largely a question mark.
OTC aspect would be awesome assuming safety/price are achievable. I assume safety is largely a slam dunk so the question is whether at-scale manufacturing can lower the price to compete with unregulated products. Exciting to think that will be a question to answer!
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Post by markado on Jul 12, 2022 12:06:47 GMT -5
Just saw this regarding another unrelated potential drug: "To move from prescription to OTC, drug makers must prove the drug can be used safely and effectively by consumers without supervision from a healthcare provider and must have a low potential for misuse and abuse". This of course is obvious. It sure seems like RLS has the potential to accomplish this and this could possibly be why Andrea Leone-Bay joined RLS. Maybe someone can provide better clarity regarding this challenge and potential. If ultra-rapid calming could be safely provided OTC, the potential would be nothing short of a Blockbuster. If GSK can move Voltaren from Rx to OTC with a box warning, I certainly think that RLS or a licensee could take a non-prescription version of inhalable CBD (which is already approved in certain states as marijuana) to OTC. It might fall in similarly with melatonin, valarian root, etc. Might make for a good sleep aid - and that's a huge category. Several people I know suffer from mind spaghetti, when they wake up at night. It's the barrage of to-do's, what-if's and oh-no's that keep them up. I think a good dose of who-cares might help.
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Post by prcgorman2 on Jul 12, 2022 13:02:04 GMT -5
I can see it now in my minds eye as an older T2. Dreamboat on the night stand with two sets of cartridges. Just need to be careful which ones I'm inhaling for which purpose.
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Post by cretin11 on Jul 12, 2022 13:19:02 GMT -5
The CBD product would seemingly be a slam dunk for OTC if RLS wants to go that route. The potential for misuse/abuse is extremely low, given the non-toxicity of CBD generally. However, IMO there’s not much blockbuster potential because of the already saturated market. Assuming price point will have to be at or higher than currently available CBD products, the rapid onset isn’t enough of a differentiator (for OTC market), because CBD tinctures already offer onset of effects within minutes. i generally agree with you here, but in the famous (at least to baseball fans in the 80's) word of Joaquin Andujar, "youneverknow".
Ive used tinctures but not a fan and would try a dreamboat / ti in a heartbeat.
I remember Joaquin pitching for the Lastros back in the day. “Youneverknow” is probably a good way to handicap the odds of dreamboat CBD making a big splash in OTC market. Even the local grocery store already has a sizable CBD section, it’s become so accepted and prevalent. No reason why a dreamboat RLS product can’t go there too. It’ll be all about the price point.
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Post by prcgorman2 on Jul 12, 2022 13:21:41 GMT -5
Just saw this regarding another unrelated potential drug: "To move from prescription to OTC, drug makers must prove the drug can be used safely and effectively by consumers without supervision from a healthcare provider and must have a low potential for misuse and abuse". This of course is obvious. It sure seems like RLS has the potential to accomplish this and this could possibly be why Andrea Leone-Bay joined RLS. Maybe someone can provide better clarity regarding this challenge and potential. If ultra-rapid calming could be safely provided OTC, the potential would be nothing short of a Blockbuster. If GSK can move Voltaren from Rx to OTC with a box warning, I certainly think that RLS or a licensee could take a non-prescription version of inhalable CBD (which is already approved in certain states as marijuana) to OTC. It might fall in similarly with melatonin, valarian root, etc. Might make for a good sleep aid - and that's a huge category. Several people I know suffer from mind spaghetti, when they wake up at night. It's the barrage of to-do's, what-if's and oh-no's that keep them up. I think a good dose of who-cares might help. Wouldn't it be great to see advertisements for an OTC version?
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Post by akemp3000 on Jul 12, 2022 13:33:36 GMT -5
IMO, it's difficult to accept the RLS/Mannkind offering would merely be similar to other OTC options. The nano particle delivery system into the deep lungs would seem to be significantly faster acting with better drug delivery control than current OTC options. I admit to knowing little about the science, just thinking out loud. I would also bet Andrea Leone-Bay believes they can capitalize on differentiation.
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Post by cretin11 on Jul 12, 2022 14:00:18 GMT -5
IMO, it's difficult to accept the RLS/Mannkind offering would merely be similar to other OTC options. The nano particle delivery system into the deep lungs would seem to be significantly faster acting with better drug delivery control than current OTC options. I admit to knowing little about the science, just thinking out loud. I would also bet Andrea Leone-Bay believes they can capitalize on differentiation. We're all just speculating until we get any visibility from RLS on it, but I bet Andrea realizes the price point will be an issue with OTC and therefore the focus instead will be via doctors prescribing it. TS delivery should be faster than other methods, but the question how much more will a typical customer pay for it. The OTC shopper will be able to compare prices and decide on the less expensive option that still works fine, even if it takes a few more minutes for the effect. On the other hand, the patient at a doctor's office will take whatever the doc prescribes. That's the likely better avenue for RLS.
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Post by prcgorman2 on Jul 12, 2022 14:43:17 GMT -5
Just saw this regarding another unrelated potential drug: "To move from prescription to OTC, drug makers must prove the drug can be used safely and effectively by consumers without supervision from a healthcare provider and must have a low potential for misuse and abuse". This of course is obvious. It sure seems like RLS has the potential to accomplish this and this could possibly be why Andrea Leone-Bay joined RLS. Maybe someone can provide better clarity regarding this challenge and potential. If ultra-rapid calming could be safely provided OTC, the potential would be nothing short of a Blockbuster. I agree. I wonder if Mango or others have any statistics on sales of OTC versions of what were initially Rx?
I found an article on Rx-to-OTC switches from 2021 predicting $35B OTC market (CAGR 5.3% over 10 years) with "allergy and respiratory drug segment" the leader with almost 28% ($9.8B).
GSK's Flonase sold about $229M in 2019. A CBD OTC seems almost a certainty at some point. And, it could conceivably sell 5x of Flonase. Why not RLS103?
$100M in royalties here, and another $100M in royalties there, and pretty soon you're talking real money. (Paraphrasing the late Sen. Everett Dirksen.)
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