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Post by matt on Oct 26, 2016 11:22:40 GMT -5
I'm not sure. There is also the downstream problem that once it is approved you have to get it adopted by each of the national health systems or you have a drug that can be sold but no customer. For anything like a filing with EU for a new drug approval, it is far more than paying the filing fee and submit the application, I would imagine you will need a team of dedicated people to prepare the filing to the best you can and coordinate with the approval authority (EU central and then on a national level, as necessary) on many issues. Yes, and no. A filing with the EU is not dissimilar to an FDA filing, but since the major drug authorities around the world have gone to the use of CTD (Common Technical Documents) the vast majority of the data that EMA will look at has already been prepared for FDA in the same format. There is some supplemental information required, but it is not too bad. Still, it is a committee driven process and it takes some people management to get it done.
Where you are wrong is that a decision by EMA is binding on all countries and there are no national drug approvals required in addition to EMA. There are reimbursement decisions take on a national or regional level and the generosity of funding varies dramatically from one part of Europe to the other. Germany, Austria, Netherlands, and the Nordic countries are well funded, most of the Southern / Mediterranean countries are very poorly funded, and the rest (UK, France) are somewhere in the middle. In some countries it is the state or provincial government that provides most of the healthcare funding so you can't even generalize within some countries. In Spain, for example, the local government in Madrid has historically has paid drug bills in 180 days while some of the outlying provinces can take up to 500 days to pay. Germans regularly pay their drug bills in 20 days. Europe remains a place on the map and not a unified system of government.
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Post by zuegirdor on Oct 26, 2016 12:28:17 GMT -5
For anything like a filing with EU for a new drug approval, it is far more than paying the filing fee and submit the application, I would imagine you will need a team of dedicated people to prepare the filing to the best you can and coordinate with the approval authority (EU central and then on a national level, as necessary) on many issues. Yes, and no. A filing with the EU is not dissimilar to an FDA filing, but since the major drug authorities around the world have gone to the use of CTD (Common Technical Documents) the vast majority of the data that EMA will look at has already been prepared for FDA in the same format. There is some supplemental information required, but it is not too bad. Still, it is a committee driven process and it takes some people management to get it done.
Where you are wrong is that a decision by EMA is binding on all countries and there are no national drug approvals required in addition to EMA. There are reimbursement decisions take on a national or regional level and the generosity of funding varies dramatically from one part of Europe to the other. Germany, Austria, Netherlands, and the Nordic countries are well funded, most of the Southern / Mediterranean countries are very poorly funded, and the rest (UK, France) are somewhere in the middle. In some countries it is the state or provincial government that provides most of the healthcare funding so you can't even generalize within some countries. In Spain, for example, the local government in Madrid has historically has paid drug bills in 180 days while some of the outlying provinces can take up to 500 days to pay. Germans regularly pay their drug bills in 20 days. Europe remains a place on the map and not a unified system of government.
Well, the FDA botched so many trial components its hard to recommend following too closely in those tracks.
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Post by bwills on Oct 26, 2016 18:58:17 GMT -5
I just noticed the link just takes you to the search function. To see "Approval History, Letters, Reviews, and Related Documents," you have to search for afrezza and then click on the related link.
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Post by rockstarrick on Oct 26, 2016 21:23:07 GMT -5
"If I was Matt", after reading or hearing all of the insults before and after our conference calls for the last few years, I just wouldn't say anything, (I'm not CEO material, FYI). I have read these insults, pages and pages of Matt bashing, by several different investors, on several different social media forums. Im just pointing out that Matt is dammed if does, and dammed if he doesn't, there is no argument here, this is a completely true statement. I don't blame Matt for not speaking because of this. I don't think there is a mnkd investor, long or short, who isn't just dying to know what the hell happened over the last few years, I know I am. The old saying is, "if you can't stand the heat, then you should get out of the kitchen." Agree 100% Obviously Matt can take it, I'm behind him all the way, no matter what happens.
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Post by MnkdWASmyRtrmntPlan on Oct 27, 2016 19:34:07 GMT -5
I just noticed the link just takes you to the search function. To see "Approval History, Letters, Reviews, and Related Documents," you have to search for afrezza and then click on the related link. Yes, I found it from your original post. That's a really good link. All the labels are there for all the changes of all pharmaceuticals. We'll have to save that as a favorite and keep checking it. Thanks, bwills
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