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Post by agedhippie on Jun 28, 2019 14:46:18 GMT -5
I would be very surprised if Afrezza didn't pass EMA but it will not be quick. I am not really clear on why they didn't file years ago as there is minimal commitment on Mannkind's side. Once you have cleared EMA you can market the drug in Europe, but now you hit the real hurdle - the national health services. Although the drug is approved that doesn't mean a health system will pick it up. In the UK the next hurdle is NICE which decides if the benefits justify the price. This is a very mechanistic process and heavily data driven where outcomes need to be quantifiable. For example saying Afrezza gives few complications would require trial data showing exactly what those numbers are - no trial data no claim. If it gets past NICE then each regional budget holder needs to decide if they want to buy it. Just because NICE approves a drug doesn't mean it necessarily ever gets prescribed. Independently of the NHS doctors can prescribe a drug that is not approved by NICE or budgeted, it's just that the patient has to pay for those out of pocket. The cost @ $250,000 to apply? Fire one of the overpaid and underemployed Mannkind executives and you could have the filings and still have changes over Alternately, and more realistically (sadly), take it out of the ineffectual marketing budget. We can spend $9M on a useless TV campaign, but not $0.25M on European marketing approval.
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Post by goyocafe on Jun 28, 2019 14:52:23 GMT -5
The cost @ $250,000 to apply? Fire one of the overpaid and underemployed Mannkind executives and you could have the filings and still have changes over Alternately, and more realistically (sadly), take it out of the ineffectual marketing budget. We can spend $9M on a useless TV campaign, but not $0.25M on European marketing approval. Just wait for the rest of the world to adopt. Let them ask Mannkind to ship the product to the U.K. for the benefit of PWDs there. Enough trying to convince the bureaucrats what they need. The story will eventually speak for itself.
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Post by agedhippie on Jun 29, 2019 8:20:05 GMT -5
Fire one of the overpaid and underemployed Mannkind executives and you could have the filings and still have changes over Alternately, and more realistically (sadly), take it out of the ineffectual marketing budget. We can spend $9M on a useless TV campaign, but not $0.25M on European marketing approval. Just wait for the rest of the world to adopt. Let them ask Mannkind to ship the product to the U.K. for the benefit of PWDs there. Enough trying to convince the bureaucrats what they need. The story will eventually speak for itself. That is going to be a long wait. The bureaucrats in Europe are the gatekeepers just like the insurers in the US and they have processes for drug approvals. Those processes are driven by large scale trials and right now the only one out there is Affinity which is not exactly compelling.
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