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Post by rrtzmd on Nov 18, 2015 11:47:37 GMT -5
"Insurance (formulary placement and prior authorization), spirometry test, and pricing were generally reorganized roadblocks."
And in the past 10 months, what can be documented that SNY has done about any of those issues? What can be documented that SNY will do about any of those issues? Tough to succeed if someone doesn't remove the "roadblocks."
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Post by rrtzmd on Nov 18, 2015 0:21:45 GMT -5
FWIT, for your information: 1. It appears this mysterious "human insulin" first appeared in EMA's "Medicines under evaluation" list in July 2014. So it appears the application was first submitted and accepted by EMA in or around July 2014. 2. When it was on the list, Insulin glargine (apparently, Toujeo) was also grouped in the same list as " Non-orphan generic and biosimilar medicinal products", the same as this mysterious "human insulin". 3. In November 2012, there was also a "human insulin" applications (actually noted as 3 applications in total) in the same list as "Non-orphan generic and biosimilar medicinal products", but it then disappeared in the subsequent lists (though I did not verify each list to confirm this) and apparently until the same name reappeared in the July 2014 list. 4. It appears Insulin glargine (apparently, Toujeo) first appeared in EMA's "Medicines under evaluation" list in July 2013. So it appears the application was first submitted and accepted by EMA in or around July 2013. Considering that Toujeo obtained CHMP opinion in Feb 2015 and official EMA approval in April 2015, the whole process took about two years for Toujeo. So whatever this mysterious "human insulin" turns out to be, if it gets CHMP opinion this month and official EMA approval in Jan. 2016, that's not too shabby. The above information is from EMA's website at: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/document_listing/document_listing_000349.jsp&mid=WC0b01ac05805083eb#section1There is really nothing mysterious that I can see. The October meeting lists one application for insulin under "Non-orphan generic and biosimilar medicinal products." Obviously, afrezza is not a generic. If you look at how the agency defines "biosimilar": defining biosimilar...and look under "Application of the biosimilar approach" on pages 4 and 5, it should be obvious that afrezza does not qualify. Although several of the details would likely disallow it, perhaps the most relevant is probably this one: "The posology and route of administration of the biosimilar must be the same as those of the reference medicinal product." While "route of administration" could make afrezza similar to exubera, posology -- referring to dosing -- is completely different than any other product -- at least I can think of no other drug that doses by blue and green cartridges. Hence, whatever insulin is being referred to as having an application under "generic and biosimilar" extremely unlikely to be afrezza.
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Post by rrtzmd on Nov 17, 2015 23:50:18 GMT -5
I did, but nothing changed. Do you have any additional insight to offer? Has MNKD ever specified what exactly is required to get insulin qualified? From Morgan Stanley conference (9/14): “It’s natural that Sanofi would like to supply us with insulin that makes sense for both of us,” Pfeffer told investors. “They can certainly make it more cheaply then we can buy it anywhere else, which only helps both of us since this is off the bottom-line which we then split.” However, if Sanofi is to supply the insulin API for Afrezza it will have to be approved which is “not a trivial process,” according to Pfeffer. “ It is not terribly complex, but it takes some time.” Mannkind’s President Hakan Edstrom added: “We are certainly eager to qualify the Sanofi insulin as quickly as we can since we will provide them all products at cost and certainly buying it from a third party as having a profit share arrangement with the close partner." So it's been 14 months since Pfeffer said "it takes some time." How much more time should be anticipated? After the Amphastar agreement runs out in four years? Currently, at least, it doesn't appear that Sanofi "would like to supply" insulin to MNKD. Quote: Do you have any additional insight to offer? if Sanofi is to supply the insulin API for Afrezza it will have to be approved which is “not a trivial process,” according to Pfeffer. Reply; Yes, I do have additional insight. You said it would take a phone call and then you posted it takes more than a phone call. I see you thought about it enough to find out, it takes more than a phone call. This discussion is over for me.
"You said it would take a phone call..." No, I said I thought it would take little more than a "phone call" given the huge amount of insulin SNY already sells in the United States. Does anyone see any reason why it should take 14 months or longer? Is SNY even attempting to get qualified to supply insulin to MNKD?
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Post by rrtzmd on Nov 17, 2015 13:21:09 GMT -5
From the post directly above; It does not have anything to do with afrezza. Afrezza is not human insulin! It is afrezza -- human insulin encapsulated in FDKP particles. When its application is filed, it will have to be for the drug, afrezza. Fourth post in this thread; Some people think this application is for Afrezza and that Sanofi has been granted anonymity by the EMA. If so, the decision to authorize will be made within 45 days, if no issues remain unresolved. There are many people who think that this EMA case is NOT related to Afrezza (such as the use of "biosimilar" in describing the drug) but I think we should be able to put the debate to bed soon. Agree Peppy, If Afrezza has to be submitted by name, why would the EMA allow any human insulin drug to be listed as "Insulin Human" no name listed ?? Because "human insulin" is just that -- human insulin. Humulin R, for example, is just human insulin -- recombinant, yes, but still just plain human insulin. Any generics of humulin R therefore qualify as being called "human insulin." Afrezza is a separate drug -- a combination of human insulin with FDKP particles. As such it has its own specific name and that is the name it must use to apply for approval.
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Post by rrtzmd on Nov 17, 2015 13:07:43 GMT -5
Indeed, SNY sells tons of insulin in the US, I would think little more than a phone call to the FDA would have been sufficient. After all, afrezza uses just humalin R -- nothing fancy. And, as I understand it, MNKD has a warehouse full of Pfizer insulin that could be "qualified" as well. I have yet to understand why MNKD would allow itself to be bound to an agreement with Amphastar for five years before anyone had a remote idea of what the demand would be. If anything, why wasn't it SNY that signed the deal with Amphastar so "qualified" insulin could be provided to MNKD? SNY is in much better condition to handle any supply/demand issues than MNKD, plus it would have been an incentive for SNY to put more energy into promoting afrezza. Think again. I did, but nothing changed. Do you have any additional insight to offer? Has MNKD ever specified what exactly is required to get insulin qualified? From Morgan Stanley conference (9/14): “It’s natural that Sanofi would like to supply us with insulin that makes sense for both of us,” Pfeffer told investors. “They can certainly make it more cheaply then we can buy it anywhere else, which only helps both of us since this is off the bottom-line which we then split.” However, if Sanofi is to supply the insulin API for Afrezza it will have to be approved which is “not a trivial process,” according to Pfeffer. “It is not terribly complex, but it takes some time.” Mannkind’s President Hakan Edstrom added: “We are certainly eager to qualify the Sanofi insulin as quickly as we can since we will provide them all products at cost and certainly buying it from a third party as having a profit share arrangement with the close partner." So it's been 14 months since Pfeffer said "it takes some time." How much more time should be anticipated? After the Amphastar agreement runs out in four years? Currently, at least, it doesn't appear that Sanofi "would like to supply" insulin to MNKD.
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Post by rrtzmd on Nov 17, 2015 12:33:51 GMT -5
Does anyone have information on this topic? It seems qualifying sny's insulin should be a realistically easy process. After all we are just talking about raw material already in use, correct? This could be a major catalyst considering it comes with a $25m payment and increases profit margins significantly I would think. Indeed, SNY sells tons of insulin in the US, I would think little more than a phone call to the FDA would have been sufficient. After all, afrezza uses just humalin R -- nothing fancy. And, as I understand it, MNKD has a warehouse full of Pfizer insulin that could be "qualified" as well. I have yet to understand why MNKD would allow itself to be bound to an agreement with Amphastar for five years before anyone had a remote idea of what the demand would be. If anything, why wasn't it SNY that signed the deal with Amphastar so "qualified" insulin could be provided to MNKD? SNY is in much better condition to handle any supply/demand issues than MNKD, plus it would have been an incentive for SNY to put more energy into promoting afrezza.
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Post by rrtzmd on Nov 17, 2015 12:21:26 GMT -5
any truth to this?
the agenda for the CHMP evaluation meeting 19-22 Oct is out . Pre authorisation process : Insulin Human (003858) : oral explanation given tomorrow 10/20
I tried going through search and got lost looking at the link. I saw insulin, technosphere I did not see.
2.1.1. - insulin human - EMEA/H/C/003858 treatment of diabetes Scope: Oral explanation Action: Oral explanation to be held on Tuesday 20 October 2015 at 9.00. List of Outstanding Issues adopted on 25.06.2015. List of Questions adopted on 23.10.2014.
My attempt to keep this thread on topic. It does not have anything to do with afrezza. Afrezza is not human insulin! It is afrezza -- human insulin encapsulated in FDKP particles. When its application is filed, it will have to be for the drug, afrezza.
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Post by rrtzmd on Nov 17, 2015 0:33:35 GMT -5
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Post by rrtzmd on Nov 16, 2015 11:02:48 GMT -5
I believe there are really only a couple of truly substantive issues at this point:
1. What is planned as regards the spirometry problem? So far, MNKD management has reassured that SNY is working on it but has provided no details that I could find as to what is being done or how successful it has been.
2. What is planned to address the third party payor problem? Will SNY lower the price of afrezza to meet the competitors' prices? Will they initiate a suitable trial to assess prove afrezza deserves a better label? When? How long will it take?
Without answers to those first, it doesn't hardly seem worth the effort to discuss anything else.
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Post by rrtzmd on Nov 16, 2015 10:52:41 GMT -5
For your information, I have just added a number 8 to my original post. 8. Have someone (Al Mann, Hakan, Matt or some Afrezza uses like Sam, etc.) appear in popular shows/reports like The Oprah Winfrey Show, 60 minutes, etc.
Sanofi and Mannkind should line up with some popular shows/reports like The Oprah Winfrey Show, 60 minutes, etc. Need not be too fancy or too promotional. Just need to reveal to the world that we have this new weapon to fight against diabetes. It would be great if Al Mann himself can do it. But Hakan, Matt or some Afrezza uses like Sam will also do a great job. Just demonstrate the dreamboat and breathe a couple time would be great. I do not think this will be that expensive and this will increase the awareness of Afrezza greatly. And I think Sanofi and Mannkind will be to line up such appearances if they take this seriously. Please stop. Respectfully, you have no idea what management is doing and your suggestions are not helping. Let them do their jobs, please. Just because you might own some shares does not give you the right to think that top management have nothing better to do than picking up your calls. Please stop. There is much more going on of which you have no idea. Shareholders will be informed when there is proper news to be announced. Thank you. "Just because you might own some shares does not give you the right to think that top management have nothing better to do than picking up your calls..." I beg your pardon but being a CEO or CFO does not translate into assuming the powers of an autocrat free of criticism and free of any responsibilities to the peasants -- aka shareholders! As a shareholder, it is your equity at stake whether you own a hundred shares or a hundred million shares. Any shareholder is well within rights to complain about anything seen fit. Also well within rights is filing suit and seeking damages if management has not lived up to its fiduciary responsibilities.
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Post by rrtzmd on Nov 13, 2015 10:44:04 GMT -5
The ETFs have to purchase a certain amount based on current value for proper market weighing. So they chose to purchase 13mil through the offering and will be purchasing the rest on the open market (not through MNKD's offering). They have until Sunday to purchase as many shares as the need to purchase on the open market. This will conceivably benefit the PPS but only raised $33mil for MNKD. The good news is that the ETF funds would not be purchasing shares if they were concerned about the long-term future viability of the company. This puts to rest the Adam F. theory that the sky is falling on the company. As I understand it, the ETFs were mandated to buy MNKD once it became listed. That was the gripe in some of the Israeli articles I quoted previously -- MNKD only listed there in order to take advantage of TASE rules to raise money. Indeed, some of the complaints had to do with Israeli investors being forced to accept the risk of MNKD's "future viability."
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Post by rrtzmd on Nov 13, 2015 10:19:28 GMT -5
FYI..SNY rep I know stated they had best week to date regarding scripts, one physician who had been totally resistant also did his first script...said they are working diligently on the insurance...hopefully it gets extrapolated across the board and is reflected some nice #'s tomorrow to piggyback today's action Quoting from someone on SA claiming direct access: "Week ending Nov 6 NrX of Afrezza of 335 vs 363 the week before TrX of Afrezza of 560 vs 583 the week before" I don't know that I can have a lot of confidence in what the rep said.
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Post by rrtzmd on Nov 13, 2015 10:10:58 GMT -5
Jeremg, that is a very good point. The terms he was referring to might well have changed between CC and closing of the deal. I suspect somewhat that a prohibition on lending in this form may stem from a cultural practice, but I certainly don't know. I am fascinated by the idea that the funds approached MNKD rather than other way around. What exactly was the motivation to list on TASE? Here are some quick thoughts, are there others? 1) Knowing about share lending lockup - MNKD simply hoped to squelch the short pool through the index funds 2) Following the lead of other companies, MNKD wished to raise capital indirectly by creating demand through the funds and later selling in the market 3) MNKD simply wanted to reach a different pool of investors (individual) through the TASE 4) MNKD expects to engage in other business in Israel in the near future 5) Matt was fudging when he said funds approached MNKD to suggest buying direct My own opinion is that the only reason MNKD listed in Tel Aviv was to take advantage of the ETF mandated rebalancing. That gave MNKD a "captive audience." Several of the articles I read from Israel that I quoted elsewhere were quite down on MNKD coming in and "looting" Israel for money by taking advantage of that rule. Indeed, the ideal source of financing would have been Sanofi. Sanofi is, after all, MNKD's partner. Sanofi depends upon MNKD for its supply of afrezza and presumably wouldn't want that supply disrupted by MNKD's financial problems. SNY is wealthy and could easily have afforded to buy 25 million shares for 4 bucks a share. Or the money could even been taken as an advance on a future milestone. Either way, think what an impression that would have made on the market. SNY would be demonstrating clearly their confidence in afrezza and the MNKD deal. It would have alleviated considerable financial woe for MNKD and likely made further financing more easily accessible. The stock would have gone up who knows how high on the news. Look what you have now -- more uncertainty. MNKD got only an additional 36 million dollars -- hardly enough to cover 4 months burn. After that -- what? Then there's uncertainty about what the ETFs can do with those shares. My own analysis suggests that unless MNKD has a contract signed by the ETF managers saying they won't lend out the shares under any circumstances, the TASE has no restriction about ETFs lending shares via the NASDAQ.
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Post by rrtzmd on Nov 12, 2015 10:22:40 GMT -5
Sounds like a mystery novel in the making - "The Israeli Gambit". One thing about "The Israeli Gambit" is the potential for "blowback." Reading several articles on "calcalist" suggests quite a few people are upset at MNKD taking advantage of an Israaeli rule mandating ETF purchases of new listings. One article was about biotechs there getting their share prices knocked down in order to accommodate MNKD. Another resented a US company pillaging Israel for millions of dollars. Another discussed the effects on retirement accounts. Per the story that led to the "rumor," regulators are already taking some sort of actions regarding future offerings. There's an old saying about "an ill wind that blows nobody good."
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Post by rrtzmd on Nov 11, 2015 22:28:23 GMT -5
finance.yahoo.com/news/mannkind-confirms-planned-stock-sale-211150487.htmlI deliver on my promise. Yours ? VALENCIA, Calif., Nov. 11, 2015 (GLOBE NEWSWIRE) -- MannKind Corporation (MNKD.TA) (MNKD.TA) today announced that its shares will enter the following Tel Aviv Stock Exchange, or TASE, indexes as planned on November 15, 2015: TA-100, TA-75, TA-Composite, TA-Biomed, TA-Blue-Tech and TA-Tech-Elite. The Company is reconfirming its expectation of completing a previously-announced registered direct offering of its common stock to selected investment funds in Israel that are required to hold securities included within certain stock indexes of the TASE. The final number of shares to be sold in the offering will be determined based upon the number of shares the purchasers are required to hold within the indexes, and subject to the purchasers' desired allocation amounts. The shares will be issued pursuant to the Company's effective registration statement on Form S-3 (File No. 333-333-206778) and are being offered pursuant to a related prospectus supplement filed with the Securities Exchange Commission on November 9, 2015. Copies of the prospectus supplement and accompanying prospectus are available on the SEC's website located at www.sec.gov and may also be obtained by contacting the Company at 25134 Rye Canyon Loop, Suite 300, Valencia, CA 91355, Attn: Investor Relations, or by telephone at (661) 775-5300. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the shares in any state or other jurisdiction which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The shares sold in the offering will trade on the Nasdaq Global Market as well as the TASE. According to the Israeli Securities Authority's announcement to the Company on November 11, 2015, certain restrictions will apply to the issued shares on TASE under the Israeli Securities Authority. Trading Regulations The Company's shares will continue to be listed on the Nasdaq Global Market, subject to the rules and regulations of the Nasdaq Global Market applicable to listed companies. Under Israel's Dual Listing Law, U.S.-listed companies may also list on the TASE without substantial additional regulatory requirements. Investors should note that trading on the TASE occurs Sunday through Thursday from 8:30 am to 4:30 pm Israel time, except on TASE trading holidays, and trading on the Nasdaq Global Market occurs Monday through Friday, 9:30 am to 4:00 pm Eastern Time, except on Nasdaq holidays. The TASE Clearing House is electronically linked to the Depository Trust Company, a subsidiary of the Depository Trust & Clearing Corporation, to automate the cross-border settlement of shares listed on both the TASE and a U.S. Exchange. Why did it take so long? Releasing the news 7-8 hours after the market is reacting to a story and after the exchanges have closed might not go over well with institutional investors.
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