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Post by kc on Aug 4, 2014 16:09:15 GMT -5
its in Romanian---- Thank you Google. Central Depository registered RoClear financial instruments issued by MannKind Corporation Central Depository registered clearing-settlement and registry RoClear to conduct cross-border settlement transactions, financial instruments issued by MannKind Corporation, a release of DC, sent Monday AGERPRES. According to the document, it is about shares (symbol: MNKD) stock listed on NASDAQ, Frankfurt Stock Exchange, Berlin Stock Exchange Munich Stock Exchange Stuttgart Stock Exchange, TradeGate, BATS U.S.. The depositary is U.S. DTC. According to the Central Depository MannKind Corporation is a biopharmaceutical company focused on discovering, developing and commercializing therapeutic products for patients diagnosed with diseases such as diabetes. This is very good news if it gives MNKD access to other exchanges outside the USA. I had assumed they were listed already on overseas exchanges. Access will make the stock pop even more.
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Post by zieg on Aug 5, 2014 10:58:43 GMT -5
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Post by kc on Aug 5, 2014 19:25:01 GMT -5
old article from September 2013. But my point for posting is this paragraph regarding approval in other countries. Especially the EU where drugs have to pass the EMA. blog.pharmexec.com/2013/09/18/ever-bullish-al-mann-says-afrezza-is-coming-in-mid-april/Al Mann was less ambiguous, in a phone conversation with PharmExec. “I would expect it to be approved in mid-April [2014],” says Mann. “On our schedule it looks like April 14, but it could be a few days before or after .” Mann says his company will file in Europe shortly after completing the US submission. Mann says other markets are looking to the FDA and EMA as a guide on this product; however, “a number of countries are talking about approving [Afrezza] simultaneously…and one country is even talking about doing it before the US.” Which country is that? Mann wouldn’t say. So you have to wonder what is really going on as perhaps we are closer to EU approval and the signed purchase agreement for Insulin from (July 31, 2014) Amphastar France Pharmaceuticals S.A.S., a French corporation will help it win approval more timely with the EMA since its an approved EU production facility?
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Post by 4allthemarbles on Aug 5, 2014 21:59:42 GMT -5
EU approval?
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Post by ashiwi on Aug 6, 2014 20:33:30 GMT -5
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Post by chauffe00 on Aug 6, 2014 22:26:49 GMT -5
Muchas gracias! Good read!
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Post by seanismorris on Aug 8, 2014 12:20:01 GMT -5
Interesting news...could be the tip of the iceberg or Pfizer confronts surge of lawsuits over Lipitor Reuters: Pharmaceutical giant Pfizer Inc. is facing a mounting wave of lawsuits by women who allege that the company knew about possible serious side effects of its blockbuster anti-cholesterol drug Lipitor but never properly warned the public. In the past five months, a Reuters review of federal court filings shows, lawsuits by U.S. women who say that taking Lipitor gave them type-2 diabetes have shot up from 56 to almost 1,000. Plaintiffs' lawyers say women are more at risk of developing diabetes than are men. Read more: www.businessrecord.com/Content/Default/-All-Latest-News/Article/Morning-Business-Headlines/-3/248/64814#ixzz39p09cHMVFYI LIPITOR ... More than 29 million people in the United States have been prescribed LIPITOR.
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Post by BD on Aug 8, 2014 17:18:24 GMT -5
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Post by seanismorris on Aug 9, 2014 14:41:09 GMT -5
I was reading through an article on a new insulin pen and the author made an interesting statement. Quote But honestly, the point is moot, because patients don’t get to choose their insulin brand. In fact, doctors don’t get to choose their patients’ insulin brand anymore either. It’s often the insurance formularies that dictate which insulin we use. So if insurance companies charge you more for the Novo pens instead of the Lantus SoloStar pens from Sanofi, then it really doesn’t matter if the dosing mechanism has a push button or traditional plunger. It comes down to what insurers tell you. So the question is, do other readers agree that Doctors and patients have less control (over treatment) than we thought? And, how long does it take to get the insurers on board with Afrezza? www.diabetesmine.com/2014/08/novo-retiring-venerable-flexpen-for-new-touch.html
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Post by dreamboatcruise on Aug 9, 2014 15:10:23 GMT -5
I was reading through an article on a new insulin pen and the author made an interesting statement. Quote But honestly, the point is moot, because patients don’t get to choose their insulin brand. In fact, doctors don’t get to choose their patients’ insulin brand anymore either. It’s often the insurance formularies that dictate which insulin we use. So if insurance companies charge you more for the Novo pens instead of the Lantus SoloStar pens from Sanofi, then it really doesn’t matter if the dosing mechanism has a push button or traditional plunger. It comes down to what insurers tell you. So the question is, do other readers agree that Doctors and patients have less control (over treatment) than we thought? And, how long does it take to get the insurers on board with Afrezza? www.diabetesmine.com/2014/08/novo-retiring-venerable-flexpen-for-new-touch.htmlSome of us have never thought anything other than the fact that insurers have huge amount of control. I often see people talk about Exubera and make it sound like the cumbersomeness of the bong... oops, I mean "device"... was the root of its downfall. Certainly that didn't help things, but my understanding is that even more important than that was that it was priced such that it didn't become formulary for Medicare or most insurers. That was a huge problem. That said, Mannkind has constantly asserted that this will not be a problem with Afrezza. I'm uncertain whether production cost of Exubera prevented them from pricing appropriately to be formulary or whether it was simply a huge marketing mistake, but it appears that Mannkind (and presumably their partner) will not make the same mistake and that the production costs allow that. When one thinks about it, the complexity of the dreamboat device is far simpler than the pens... so one might expect that unless the technosphere process is hugely expensive (which it seems the company says it isn't), they should be able to match the price of pens if necessary to get payer acceptance. However, I'm sure they are hoping that they can convince insurers that patient "compliance" will be higher with a non needle, more discrete dosing solution and that they (along with partner) can convince insurers to have it as formulary and yet pay a somewhat higher price for Afrezza... with offsetting savings for the insurers from the better "compliance" by patients resulting in fewer expensive complications down the road. I believe what I've said above is simply a lizard's retelling of what many others have stated in various forums... including from company leadership.
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Post by seanismorris on Aug 9, 2014 17:20:16 GMT -5
Dreamboatcruise,
I agree that Afrezza should be competitive price wise, and their 'should' be no hang ups from insurance companies. But I see Doctors and patients driving sales of Afrezzas on its merits.
I don't like the idea of insurance companies putting barriers in the way of 'best in class' treatments in general. I trust Doctors to do their best with the information they have. I trust paper pushers (with patients health) not at all. Now that we have govt health care, I'll have to trust the Afrezza partner to know the right paper pushers to bribe.
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Post by dreamboatcruise on Aug 9, 2014 17:35:53 GMT -5
Dreamboatcruise, I agree that Afrezza should be competitive price wise, and their 'should' be no hang ups from insurance companies. But I see Doctors and patients driving sales of Afrezzas on its merits. I don't like the idea of insurance companies putting barriers in the way of 'best in class' treatments in general. I trust Doctors to do their best with the information they have. I trust paper pushers (with patients health) not at all. Now that we have govt health care, I'll have to trust the Afrezza partner to know the right paper pushers to bribe.Hopefully without setting off an entire debate of healthcare reform... there really isn't anything in it that changes the equation with regard to decisions about drug coverage or use for those of us with private insurance. The only people that now have "govt health care" that didn't already are those who didn't have coverage at all because of being too poor to afford it that now have Medicaid. Personally whether it is private insurance or the government making decisions about what to pay for based on outcomes vs expense and price negotiations... that is something that has to be done. At the end of the day we still have a completely free market medical system when it comes to drugs whereby if something isn't covered based on these cost containment decisions by the insurers... each person is always free to decide to pay for a drug on their own. It sometimes makes for a poor business model to price drugs too high... e.g. exubera... but those are decisions and negotiations that must occur between companies and the insurers.
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Post by notatool on Aug 9, 2014 19:34:53 GMT -5
Just saw this....please elaborate!
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Post by seanismorris on Aug 9, 2014 21:09:51 GMT -5
I'm not sure what the request to elaborate is on...
From what I've read, the medical system in the US is changing. Independent Doctors are being replaced by salaried positions and rural hospitals are closing. We will see if anything becomes more affordable...
Currently:
For this year’s survey on overall health care, The Commonwealth Fund ranked the U.S. dead last .
1. United Kingdom 2. Switzerland 3. Sweden 4. Australia 5. Germany & Netherlands (tied) 7. New Zealand & Norway (tied) 9. France 10. Canada 11. United States
I doubt govt overhead will make it more efficient. Doctors fear of lawsuits seem to be driving the inefficiencies and in that regard nothing has changed.
But, back on topic, Afrezza reducing hypos and hospitalizations (& reducing costs) should have a positive influence on insurance coverage. But, as long as Afrezza is 'out of pocket' I doubt we'll see Blockbuster status.
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Post by notatool on Aug 9, 2014 21:25:16 GMT -5
I messed up...I wanted KC to elaborate on the Romanian article.
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