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EXCEL MARITIME CARR Message Board

biotekchamp22 2 posts  |  Last Activity: Dec 20, 2012 1:07 PM Member since: Dec 20, 2012
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  • biotekchamp22 biotekchamp22 Dec 20, 2012 1:07 PM Flag

    Cmon, why are you assuming their is no off label use of this product? Just curious. I agree with the bulk of your take, however the REMS carries much more significance than you might think. I agree that there is a lack of patients "on label" and I do not follow the arthritis avenue or KD comments either. I do not know where these pumpers get this data from, certainly not valid. This product is not even on the radar of any specialist, however off label does exist. Splitting hairs when talking about something that equates to a volume of users, whether on or off. When a product is orphan and when the drug was approved under a REMS it automatically is under the microscope to the tenth degree, this means its uses, dosing, indications, distribution, insurance availability, reimbursement, label, hippa, AE reporting, post marketing surveillance studies and clinical requirements, tight tight tight audit on call notes, marketing plans, DDMAC submissions, field messaging, etc...etc...etc.....a company better know what it is doing and have the right people promoting and selling a REMS controlled product before it launches or it will end up like K and Savient.....this is a perfect example of what can happen if you enter a market and an orphan launch as a sloppy sales organization... the value of your product and company go to a dollar. Do any of these laborious and cantankerous issues stop a true physicians from trying to prescribe K? No, of course not. But the numbers have shown us that a REMS product needs a tight sales campaign behind it, or it will look like this from a sales and results\profit standpoint very quickly.

  • biotekchamp22 biotekchamp22 Dec 20, 2012 1:07 PM Flag

    Cmon, why are you assuming their is no off label use of this product? Just curious. I agree with the bulk of your take, however the REMS carries much more significance than you might think. I agree that there is a lack of patients "on label" and I do not follow the arthritis avenue or KD comments either. I do not know where these pumpers get this data from, certainly not valid. This product is not even on the radar of any specialist, however off label does exist. Splitting hairs when talking about something that equates to a volume of users, whether on or off. When a product is orphan and when the drug was approved under a REMS it automatically is under the microscope to the tenth degree, this means its uses, dosing, indications, distribution, insurance availability, reimbursement, label, hippa, AE reporting, post marketing surveillance studies and clinical requirements, tight tight tight audit on call notes, marketing plans, DDMAC submissions, field messaging, etc...etc...etc.....a company better know what it is doing and have the right people promoting and selling a REMS controlled product before it launches or it will end up like K and Savient.....this is a perfect example of what can happen if you enter a market and an orphan launch as a sloppy sales organization... the value of your product and company go to a dollar. Do any of these laborious and cantankerous issues stop a true physicians from tyring to prescribe K? No, of course not. But the numbers have shown us that a REMS product needs a tight sales campaign behind it, or it will look like this from a sales and results\profit standpoint very quickly.

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