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EU
Oct 24, 2017 21:13:35 GMT -5
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Post by Deleted on Oct 24, 2017 21:13:35 GMT -5
During a conversation with someone knowledgeable with MannKind the topic of EU approval came up. He suggested that a possible reason no company has stepped up to partner with MannKind for Afrezza in the EU is because of cancer fear. Apparently the EU has stricter requirements for potential carcinogens than the US does; for example cosmetics have a different formulation in the EU compared to the US.
Anyone have input around this?
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Post by madog365 on Oct 24, 2017 21:23:32 GMT -5
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Post by straightly on Oct 24, 2017 21:33:55 GMT -5
And one can now add China to the list: certain drug can be marketed while data is gathered and then assessed.
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EU
Oct 24, 2017 21:38:08 GMT -5
alethea likes this
Post by thekindaguyiyam on Oct 24, 2017 21:38:08 GMT -5
During a conversation with someone knowledgeable with MannKind the topic of EU approval came up. He suggested that a possible reason no company has stepped up to partner with MannKind for Afrezza in the EU is because of cancer fear. Apparently the EU has stricter requirements for potential carcinogens than the US does; for example cosmetics have a different formulation in the EU compared to the US. Anyone have input around this? Seems like they care about their population. With time values change; Afrezza will demonstrate it's superiority elsewhere and then the EU will have a better view of those spreading the word. Afrezza users seem to be a vocal group. Had and endo appointment a couple of days ago. Took a photo of he comparison between Ultra fast Afrezza vs Novo's new Ultrafast. The #'s don't lie. First thing I said to her was "you have to see this". Afrezza in 1/2 the time out 2/3 earlier than the Novo. Faster in Faster out. Then the exam and she brings up metforman. I tell her it becomes resistant where some think type 2 can reverse diabetes. After a while she told me that if I wanted Afrezza I could have it. I don't need it right now the #'s are down, low enough that I don't want to take any extra drug if I don't need it. Including the one I'm betting the farm on. Someday the EU will get it. This is a global. I think it's a new game in spite of short interest. I think any single payer country that likes Technosphere and that gets some attention.... It's good to have a dream which has a solid foundation. how bout this. what are the most tolerant countries towards grass; and if that is ok maybe these countries would be the most flexible to the paradigm shift from needle to just breathing. www.higherperspectives.com/8-countries-that-are-a-must-visit-for-cannabis-tourism-1406170474.html
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Post by rockstarrick on Oct 24, 2017 22:26:24 GMT -5
Fyi MN: One needs to remember that the trials used for FDA approval were extended longer to accommodate for submission to EMA. Think it was about an extra month or more to the trial designs to conform to the European requirements. OOG Read more: mnkd.proboards.com/user/28/recent#ixzz4wUF7xUoy
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EU
Oct 24, 2017 22:30:00 GMT -5
via mobile
Post by ghochr on Oct 24, 2017 22:30:00 GMT -5
Lol shorty
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Post by rockstarrick on Oct 24, 2017 22:31:43 GMT -5
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Post by dreamboatcruise on Oct 24, 2017 22:35:38 GMT -5
During a conversation with someone knowledgeable with MannKind the topic of EU approval came up. He suggested that a possible reason no company has stepped up to partner with MannKind for Afrezza in the EU is because of cancer fear. Apparently the EU has stricter requirements for potential carcinogens than the US does; for example cosmetics have a different formulation in the EU compared to the US. Anyone have input around this? Mannkind went above and beyond with clinical evidence. Insulin isn't a carcinogen, and neither is FDKP... that's been shown. If someone already has a tumor, such as from smoking, does insulin delivered through the lungs possibly speed up progression... that is at least in the realm of possibility, but that isn't the same as being a carcinogen and is one of the reasons why it is contraindicated for those who smoke. IMO, that wouldn't be an issue for the EU, at least I'd hope note. I would suspect it might have to do with the national payer situation in many EU countries. Getting a drug approved as being safe and effective is only the first step in being successful there. The second, potentially larger hurdle is convincing the national healthcare systems to pay for the drug.
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Post by kc on Oct 25, 2017 10:42:11 GMT -5
Oh my you have been outed to the masses of Proboard.
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Post by matt on Oct 25, 2017 11:40:54 GMT -5
Someday the EU will get it. This is a global. It is not a matter of the EU "getting it". Like most things in Europe, the CHMP is a committee with two rapporteurs from each member state and it is largely a consensus driven process. You don't see the kind of adversarial debates and arm wrestling that are characteristic of FDA advisory panels because most of the negotiations take place quietly behind closed doors. All it takes is one rapporteur that is concerned about cancer risk to side track the process because consensus requires that nobody on the CHMP has a serious objection. An EU approval literally requires the EU parliament to pass an act, similar to an act of Congress, to finalize the approval and I am only aware of three instances where the EU parliament acted differently from the EMA recommendation. What shareholders can't know is what has happened behind the scenes. Each new drug is assigned two rapporteurs who have the job of quietly soliciting opinions from their colleagues, and working with the sponsor to resolve any issues. It is unknowable what kind of feedback has been given and how much of an effort it would be to get EMA approval. However, given the magnitude of healthcare funding in most EU countries versus Brazil, it makes more sense to push on the EU. Brazil has a lot of people, but most of those people and their national health system are both extremely poor resulting in dismal pricing. That is not the case with central and northern Europe where the Germans and the Swedes are used to paying about 80% of US prices.
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EU
Oct 26, 2017 9:40:37 GMT -5
via mobile
Post by itellthefuture777 on Oct 26, 2017 9:40:37 GMT -5
Someday the EU will get it. This is a global. It is not a matter of the EU "getting it". Like most things in Europe, the CHMP is a committee with two rapporteurs from each member state and it is largely a consensus driven process. You don't see the kind of adversarial debates and arm wrestling that are characteristic of FDA advisory panels because most of the negotiations take place quietly behind closed doors. All it takes is one rapporteur that is concerned about cancer risk to side track the process because consensus requires that nobody on the CHMP has a serious objection. An EU approval literally requires the EU parliament to pass an act, similar to an act of Congress, to finalize the approval and I am only aware of three instances where the EU parliament acted differently from the EMA recommendation. What shareholders can't know is what has happened behind the scenes. Each new drug is assigned two rapporteurs who have the job of quietly soliciting opinions from their colleagues, and working with the sponsor to resolve any issues. It is unknowable what kind of feedback has been given and how much of an effort it would be to get EMA approval. However, given the magnitude of healthcare funding in most EU countries versus Brazil, it makes more sense to push on the EU. Brazil has a lot of people, but most of those people and their national health system are both extremely poor resulting in dismal pricing. That is not the case with central and northern Europe where the Germans and the Swedes are used to paying about 80% of US prices. I imagine the EU would be an aquires problem to deal with..as Mannkimd spreads to every other continent of the planet raising value..heck their plant alone is $168 million..and scripts due tomorrow..hmm
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