Is there any chance we go back to the value investing blog that you marketed and everyone paid for?
This and the “game theory content” has been a huge deviation from what I believe the majority of readers joined for. We don’t expect every post to be a new pitch but it has been surprising how far we have come from the original blog focus.
You kidding? This stuff is gold. Can't force someone to be the way you want them to be. This kid is clearly highly intelligent. Clearpoint, Medexus, Zedcor, Cipher, etc. Let him do his thing!
If you get interested in this sort of thing take a gander at 10% crotamiton (Eurax) cream.
GoodRx says it is a prescription medicine going for a mere $600 for a 2 oz tube (60 mL) in the good ol' USA while in the UK it is over-the-counter and $8 for a 3.4 oz tube (100 mL).
We need a 1000% tariff on that pesky UK stuff or we can never ever compete!!!
"FDA agrees that spinosad, containing spinosyns A and D in a ratio of approximately 5:1, is a single active ingredient. However, we have recently approved a product [Ulesfia, discontinued in 2019] containing benzyl alcohol (present at 5%) as an active ingredient for the treatment of head lice. This would indicate that your product contains two active ingredients: spinosad and benzyl alcohol"
Nowhere can I find what percent of benzyl alcohol is present in Natroba, but it specifically is not for under certain ages.
As far as I can tell, the FDA wanted to know if benzyl alcohol was an active ingredient in treating head lice. I don't fully understand all the ins and outs here, but companies seem to get some sort of monopoly on new, unique medicines and lo and behold someone had already gotten approval of a treatment with 5% benzyl alcohol. Can't be handing out a new medicine that steps on the toes of an already granted approval, I guess. As I say, I am no expert, not a doctor or chemist, just the son of a Nobel winner and there is not even a shadow of evidence that bequeaths any expertise. "No kings" should be the motto with Nobel Prize winners, thus no princes either, I guess. In pursuing this thread I am more like one of the 7 blind men trying to feel and elephant and declare what "it" is. I wish some disinterested expert would contribute their two cents worth.
A large portion of the FDA application is focused on whether the benzyl alcohol is safe for infants, especially 0 to 6 months. In fact the report states,
"The minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity"
Further,
"Benzyl alcohol used as preservative in saline flush solutions has been associated with 16 neonatal deaths."
Oh no says the applicant, we don't need it as an active ingredient. It is a preservative and "The
applicant states that benzyl alcohol is preferred because it is a USP/NF ingredient"
It is notable that USP/NF only indicates quality in terms of product identity, purity, potency, and performance…nowhere do I see safety.
And please excuse us from having to expensive and difficult testing on infants and babies as,
"Under 21 CFR 314.55(c)(3)(i) the applicant requests a waiver of pediatric research in
infants 0 to 6 months of age.
The reasons given were that
a) Studies are highly impractical or impossible
b) The product fails to represent a meaningful therapeutic benefit over existing therapies
for pediatric patients and is unlikely to be used in a substantial number of patients in
these age groups. "
Isn't that cute? They are expressly stating their product is no better than existing products for children!
Imagine, if it were better than existing therapies, then would testing on young u's be worthwhile? Where is the logic in these arguments or justifications?
And "Golly jee, Massah FDA, doin' all dat hard testing is jess impracticable…damnation dat's a hard word! Whut's dat woid mean anyways?"
Long story short, Natroba managed to declare the benzyl alcohol an inactive ingredient and snatched approval from the jaws of disapproval by this bit of tap dancing.
The spinosad I carry does NOT contain benzyl alcohol so it is not equivalent to Natroba, thank goodness. And as far as I can discern, as no kind of expert or authority or PhD'd sort, the other ingredients are not only inactive, but also inert…and are effective if feedback is any metric.
the spinosad + vehicle cured 69% to 83% of patients and the vehicle alone cured 34% to 46% of patients. As far as I can tell "vehicle" means whatever they are stirring the spinosad into the lotion I guess.
Wait a minute. The vehicle is curing some folks…more than just a few, too, it's curing a third to almost half of patients. Without an active ingredient it is some sort of magic stuff?
How can the vehicle cure anyone if it doesn't have an active ingredient? The mind boggles. And they don't provide any testimony as to the percentage of benzyl alcohol in their vehicle. Would a bit more inactive ingredient make the vehicle as effective as spinosad alone or spinosad plus BA?
It makes me wonder if the Emperor not only has no clothes, but no royal private parts either.
I doubt this really answers your question why it has taken so long for someone to make spinosad available. It is a combination of oddities. And me hearing the haunting tune "Fools Rush In" (complete with syncopated congos) as an ear-worm when I launch into new projects.
As an aside, benzyl benzoate is my other scabies treatment product and it is not a prescription medicine, amazingly enough (according to Drugs.com). As a lotion it has been in use for a long time and yet I am the only source in the USA for this. Of course I don't sell this stuff as a medicine, but people are free to use it as they will if they take personal responsibility for the results. In the past I suspected being tiny and below the radar might have been the charm in terms of the FDA's enforcers not knocking on my door, but now, what with the FDA's radar being dismantled, I can exhale for a while.
You made me laugh and smile pleasantly at your first impressions of the presentation quality of my website at maximpulse.com
You are quite right, of course, it looks primitive because it is.
It was initially created many years ago when the web was aborning and the layout software was less pre-packaged. I could use one of the new, pretty templates and recreate my site from scratch to look more polished…but not today.
I learned a system of organization from my father which involved periodically putting everything on his desk into a shoebox and labeling it “Sort out later” with the date on it. Such boxes accumulated dust on a closet top shelf like cremated remains of pets. Meanwhile the pile grows anew and stay focused on the next thing, whatever that is.
On my website I am focused on content delivered in a useful, friendly form. A dozen years ago, when I had scabies it was misdiagnosed by many doctors and dermatologists for almost two years. While slogging through a Wikipedia page I “discovered” scabies way down an alphabetical list of something like 800 skin diseases and it sounded the closest to my symptoms. Over countless itchy, sleepless nights I researched clinical studies and programs as to what treatments were used internationally. Then I had to obtain the supplies by hook-or-crook and become my own experimental lab rat. When I was ultimately cured I created a section of my website describing what I learned and experienced. I did so out of a strong sense of duty to those who followed my tracks. I figured it would have a life of maybe a couple years as doctors would, of course, learn all about scabies and my site would become unneeded.
The ride since then has been both rewarding and disappointing. Rewarding to be able to help so many isolated and suffering people but disappointing in how doctors still get little education in scabies and what they do glean is often wrong or draws too limited of a boundary around what is allowed to be diagnosed as scabies. In other words, unless you have the right symptoms in the right places AND have others in your circle who also have similar symptoms you are left adrift. It is not uncommon for such people to be diagnosed as crazy and prescribed mind-altering drugs.
After many years of answering thousands of emails from sufferers I recently published a book, Scabies: 8 Proven Cures. It was a mammoth task and will never make any money but it is something to leave behind.
Is there any chance we go back to the value investing blog that you marketed and everyone paid for?
This and the “game theory content” has been a huge deviation from what I believe the majority of readers joined for. We don’t expect every post to be a new pitch but it has been surprising how far we have come from the original blog focus.
You kidding? This stuff is gold. Can't force someone to be the way you want them to be. This kid is clearly highly intelligent. Clearpoint, Medexus, Zedcor, Cipher, etc. Let him do his thing!
Oh, just wait until you realize the connection.
This is the very last one, Andrew. Sorry. I was amazed to see a reseller of Cipher Pharmaceuticals asset Spinosad have this connection.
If you get interested in this sort of thing take a gander at 10% crotamiton (Eurax) cream.
GoodRx says it is a prescription medicine going for a mere $600 for a 2 oz tube (60 mL) in the good ol' USA while in the UK it is over-the-counter and $8 for a 3.4 oz tube (100 mL).
We need a 1000% tariff on that pesky UK stuff or we can never ever compete!!!
The winding road to spinosad approval (as Natroba™) is as interesting as they comes.
The first FDA applications specified spinosad in a lotion containing benzyl alcohol.
https://www.fda.gov/media/80089/download
The FDA states in that record,
"FDA agrees that spinosad, containing spinosyns A and D in a ratio of approximately 5:1, is a single active ingredient. However, we have recently approved a product [Ulesfia, discontinued in 2019] containing benzyl alcohol (present at 5%) as an active ingredient for the treatment of head lice. This would indicate that your product contains two active ingredients: spinosad and benzyl alcohol"
Nowhere can I find what percent of benzyl alcohol is present in Natroba, but it specifically is not for under certain ages.
As far as I can tell, the FDA wanted to know if benzyl alcohol was an active ingredient in treating head lice. I don't fully understand all the ins and outs here, but companies seem to get some sort of monopoly on new, unique medicines and lo and behold someone had already gotten approval of a treatment with 5% benzyl alcohol. Can't be handing out a new medicine that steps on the toes of an already granted approval, I guess. As I say, I am no expert, not a doctor or chemist, just the son of a Nobel winner and there is not even a shadow of evidence that bequeaths any expertise. "No kings" should be the motto with Nobel Prize winners, thus no princes either, I guess. In pursuing this thread I am more like one of the 7 blind men trying to feel and elephant and declare what "it" is. I wish some disinterested expert would contribute their two cents worth.
A large portion of the FDA application is focused on whether the benzyl alcohol is safe for infants, especially 0 to 6 months. In fact the report states,
"The minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity"
Further,
"Benzyl alcohol used as preservative in saline flush solutions has been associated with 16 neonatal deaths."
Here is another reference on that "Neonatal Deaths Associated With Use Of Benzyl Alcohol" at https://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm
Oh no says the applicant, we don't need it as an active ingredient. It is a preservative and "The
applicant states that benzyl alcohol is preferred because it is a USP/NF ingredient"
It is notable that USP/NF only indicates quality in terms of product identity, purity, potency, and performance…nowhere do I see safety.
And please excuse us from having to expensive and difficult testing on infants and babies as,
"Under 21 CFR 314.55(c)(3)(i) the applicant requests a waiver of pediatric research in
infants 0 to 6 months of age.
The reasons given were that
a) Studies are highly impractical or impossible
b) The product fails to represent a meaningful therapeutic benefit over existing therapies
for pediatric patients and is unlikely to be used in a substantial number of patients in
these age groups. "
Isn't that cute? They are expressly stating their product is no better than existing products for children!
Imagine, if it were better than existing therapies, then would testing on young u's be worthwhile? Where is the logic in these arguments or justifications?
And "Golly jee, Massah FDA, doin' all dat hard testing is jess impracticable…damnation dat's a hard word! Whut's dat woid mean anyways?"
Long story short, Natroba managed to declare the benzyl alcohol an inactive ingredient and snatched approval from the jaws of disapproval by this bit of tap dancing.
The spinosad I carry does NOT contain benzyl alcohol so it is not equivalent to Natroba, thank goodness. And as far as I can discern, as no kind of expert or authority or PhD'd sort, the other ingredients are not only inactive, but also inert…and are effective if feedback is any metric.
To my untrained mind it is fascinating that if one looks at the results of the two tests Natroba presented here: https://www.natroba.com/scabies/efficacy/
the spinosad + vehicle cured 69% to 83% of patients and the vehicle alone cured 34% to 46% of patients. As far as I can tell "vehicle" means whatever they are stirring the spinosad into the lotion I guess.
Wait a minute. The vehicle is curing some folks…more than just a few, too, it's curing a third to almost half of patients. Without an active ingredient it is some sort of magic stuff?
How can the vehicle cure anyone if it doesn't have an active ingredient? The mind boggles. And they don't provide any testimony as to the percentage of benzyl alcohol in their vehicle. Would a bit more inactive ingredient make the vehicle as effective as spinosad alone or spinosad plus BA?
It makes me wonder if the Emperor not only has no clothes, but no royal private parts either.
I doubt this really answers your question why it has taken so long for someone to make spinosad available. It is a combination of oddities. And me hearing the haunting tune "Fools Rush In" (complete with syncopated congos) as an ear-worm when I launch into new projects.
As an aside, benzyl benzoate is my other scabies treatment product and it is not a prescription medicine, amazingly enough (according to Drugs.com). As a lotion it has been in use for a long time and yet I am the only source in the USA for this. Of course I don't sell this stuff as a medicine, but people are free to use it as they will if they take personal responsibility for the results. In the past I suspected being tiny and below the radar might have been the charm in terms of the FDA's enforcers not knocking on my door, but now, what with the FDA's radar being dismantled, I can exhale for a while.
Opps! Among other small typos,
"young u's " shoulda been "young un's ".
Where's the dang edit function when ya need it.
You made me laugh and smile pleasantly at your first impressions of the presentation quality of my website at maximpulse.com
You are quite right, of course, it looks primitive because it is.
It was initially created many years ago when the web was aborning and the layout software was less pre-packaged. I could use one of the new, pretty templates and recreate my site from scratch to look more polished…but not today.
I learned a system of organization from my father which involved periodically putting everything on his desk into a shoebox and labeling it “Sort out later” with the date on it. Such boxes accumulated dust on a closet top shelf like cremated remains of pets. Meanwhile the pile grows anew and stay focused on the next thing, whatever that is.
On my website I am focused on content delivered in a useful, friendly form. A dozen years ago, when I had scabies it was misdiagnosed by many doctors and dermatologists for almost two years. While slogging through a Wikipedia page I “discovered” scabies way down an alphabetical list of something like 800 skin diseases and it sounded the closest to my symptoms. Over countless itchy, sleepless nights I researched clinical studies and programs as to what treatments were used internationally. Then I had to obtain the supplies by hook-or-crook and become my own experimental lab rat. When I was ultimately cured I created a section of my website describing what I learned and experienced. I did so out of a strong sense of duty to those who followed my tracks. I figured it would have a life of maybe a couple years as doctors would, of course, learn all about scabies and my site would become unneeded.
The ride since then has been both rewarding and disappointing. Rewarding to be able to help so many isolated and suffering people but disappointing in how doctors still get little education in scabies and what they do glean is often wrong or draws too limited of a boundary around what is allowed to be diagnosed as scabies. In other words, unless you have the right symptoms in the right places AND have others in your circle who also have similar symptoms you are left adrift. It is not uncommon for such people to be diagnosed as crazy and prescribed mind-altering drugs.
After many years of answering thousands of emails from sufferers I recently published a book, Scabies: 8 Proven Cures. It was a mammoth task and will never make any money but it is something to leave behind.
Thanks for being the only person to even bother to sell Spinosad outside of America. I don’t know why it’s taken so long to get it anywhere.
It is a strange ol' world we live in.
Were can I get ivermection for free?
Is anyone nowhere I can get ivermection for free