OPZELURA APPROVED

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anonymous said:
Would have been better to not get approved. Just ask any Rep and they will tell you this product will not have any insurance coverage and will see even fewer prescriptions as Derms do not want all the BS that goes with writing this product.
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Ask any rep? As if reps have this insider information. It will have coverage. Insurers look at data presented to them. With step therapy, this product will have coverage. The data shows the topical is safe, regardless of the FDA label requirements. Those freaking out right now don’t have the either the knowledge or experience to adequately assess the situation and possibilities.
 






anonymous said:
Ask any rep? As if reps have this insider information. It will have coverage. Insurers look at data presented to them. With step therapy, this product will have coverage. The data shows the topical is safe, regardless of the FDA label requirements. Those freaking out right now don’t have the either the knowledge or experience to adequately assess the situation and possibilities.
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You lost me at “regardless of the FDA.” This product will fail because it is a RISK that most HCPs will not want to take on vs upcoming market entrants. Corporate Koolaid clowns on this miss this reality and the fact that payers will hammer this drug. It is doomed. No spin fixes how bad this was.
 






I am out of here as I don't need the hassle that will come with trying to sell this piece of you know what and I know many who feel the same way on my team. Saw this one coming from miles away when JAKs went down for the count.
 






anonymous said:
I am out of here as I don't need the hassle that will come with trying to sell this piece of you know what and I know many who feel the same way on my team. Saw this one coming from miles away when JAKs went down for the count.
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Just about any drug approved in this day and age in the US carries a fair amount of warnings the fda mandates. It’s a wonder anybody takes any drugs prescribed to them.
 






I saw that less than 5% of the drugs approved in the US have black box warnings so yes this is a very negative approval. Only saving grace might be that all the JAKs will have black box warnings and maybe a topical would be used before an oral JAK.
 












anonymous said:
Ask any rep? As if reps have this insider information. It will have coverage. Insurers look at data presented to them. With step therapy, this product will have coverage. The data shows the topical is safe, regardless of the FDA label requirements. Those freaking out right now don’t have the either the knowledge or experience to adequately assess the situation and possibilities.
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Truer incorrect words have never been spoken.
 






anonymous said:
You’re a Derm visiting cafepharma?! I call bullshit.
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You can call if whatever you want. Why wouldn’t we be trolling through the cess pool of Pharma? Hours of entertainment, and reinforcement of every negative stereotype about the industry written with your own keyboards. Let’s start with 1950 WAC price. Despicable greed.
Cheers, and stay out of my offices.
 






anonymous said:
Ask any rep? As if reps have this insider information. It will have coverage. Insurers look at data presented to them. With step therapy, this product will have coverage. The data shows the topical is safe, regardless of the FDA label requirements. Those freaking out right now don’t have the either the knowledge or experience to adequately assess the situation and possibilities.
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Those that are drinking the kool aide you are espousing shows the basic thinking of a non medical degreed individual. Sigh.
 






anonymous said:
You lost me at “regardless of the FDA.” This product will fail because it is a RISK that most HCPs will not want to take on vs upcoming market entrants. Corporate Koolaid clowns on this miss this reality and the fact that payers will hammer this drug. It is doomed. No spin fixes how bad this was.
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A voice of wisdom as made a brief appearance in this board. Bravo
 












anonymous said:
You can call if whatever you want. Why wouldn’t we be trolling through the cess pool of Pharma? Hours of entertainment, and reinforcement of every negative stereotype about the industry written with your own keyboards. Let’s start with 1950 WAC price. Despicable greed.
Cheers, and stay out of my offices.
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The WAC price doesn’t illustrate greed. It illustrates how expensive it is to develop and commercialize a product. Unfortunately, many do not have a clear understanding of how pricing works. Sad to see such pessimism and ignorance. Tell us how to develop a product that costs what you consider to be acceptable? Do you even know how much must be paid to the fda? Do you know what PDUFA stands for? Do some research and redirect your anger.
 






anonymous said:
The WAC price doesn’t illustrate greed. It illustrates how expensive it is to develop and commercialize a product. Unfortunately, many do not have a clear understanding of how pricing works. Sad to see such pessimism and ignorance. Tell us how to develop a product that costs what you consider to be acceptable? Do you even know how much must be paid to the fda? Do you know what PDUFA stands for? Do some research and redirect your anger.
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Right, the cost is all justified. And that’s why all the reps are making at least 130k a year plus bonus to sell a cream. oh, and a brand new Highlander hybrid. It’s all good, nothing to see here.
 












anonymous said:
I saw that less than 5% of the drugs approved in the US have black box warnings so yes this is a very negative approval. Only saving grace might be that all the JAKs will have black box warnings and maybe a topical would be used before an oral JAK.
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Not true…more like 33%
https://www.thepharmaletter.com/art...ree-chance-of-black-box-warning-or-withdrawal

Just a sign of the times and state of our FDA. In case you missed it, the oral JAKs are already approved in Europe for AD.
 






In 2020, there were over 20,000 prescription products approved by the FDA in the US, out of these 20,000 a little over 600 had black box warnings which represents 3% of all drugs. The FDA does not issue BBW for the fun of it.
 






anonymous said:
In 2020, there were over 20,000 prescription products approved by the FDA in the US, out of these 20,000 a little over 600 had black box warnings which represents 3% of all drugs. The FDA does not issue BBW for the fun of it.
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birth control has a black box, and so do antidepressants. That hasn’t stopped 50-100 M Americans from still taking them. You must be a weak salesperson. Now go out and do what you’re paid to do.
 






anonymous said:
birth control has a black box, and so do antidepressants. That hasn’t stopped 50-100 M Americans from still taking them. You must be a weak salesperson. Now go out and do what you’re paid to do.
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It’s not about US, Macho Man. It’s about PAYERS, HCP PERCEPTIONS and the upcoming competition that no one seems to properly understand (Arcutis and Dermavant) and which will be CLEAN vs us.
 






anonymous said:
It’s not about US, Macho Man. It’s about PAYERS, HCP PERCEPTIONS and the upcoming competition that no one seems to properly understand (Arcutis and Dermavant) and which will be CLEAN vs us.
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Macho, macho man (macho man)
I gotta be a macho man
Macho, macho man
I gotta be a macho
Macho, macho man
I gotta be a macho man
Macho, macho man (yeah, yeah)
I gotta be a macho
 












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