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Post by rrtzmd on Nov 11, 2015 22:23:42 GMT -5
Regarding the Israel deal? I see a ton of information but am curious if you can direct me to a timeline of what happened...thank you in advance if it exists I think it began with a couple of articles from Israel criticizing the deal and implying regulators were looking at possibly doing something. One article was this: calcali article...which translates: "Mankind issuance of cancellation; Will be denied future entry of foreign indices Mankind will issue shares for the ETF will be blocked for sale in Tel Aviv, but may be sold in the United States. To prevent the entry of foreign companies in other indices, the stock market has determined that only companies with an Israeli connection could be included in the index." But studying the article actually indicates that the problem was a six month lock-up on ETF shares sold in Israel, and that the "block" was overridden because the ETFs could still sell the shares on the NASDAQ in New York. Typical of rumors, things got worse before they got better. |
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Post by rrtzmd on Nov 11, 2015 11:57:39 GMT -5
Company with my name, technology, and patents... Here ya go. My life's work down the drain. I have so much else to live for and do with my money. Here ya go SFY! I'll just go die. Doubt it. Well, Mr. Mann can always bask in the glory of a lot of other achievements. I don't know that any misjudging of afrezza would tarnish his record. He certainly hasn't done much to help the past several months. Maybe he has come to the conclusion that afrezza isn't economically viable. |
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Post by rrtzmd on Nov 11, 2015 11:45:48 GMT -5
Contrary to popular sentiment here, AF has NOT confirmed that the financing deal is dead. He only drew attention to what the Globes paper wrote, and posted that he was personally "still trying to confirm cancellation of TASE financing". He has NOT yet confirmed this on his twitter feed. His most recent post still says "IF MNKD can't raise new cash via Israel". That was only an IF. The Schwab article is also reporting on possibilities, not yet confirmed fact. Of course, the real market players may know something more definite via Bloomberg terminals etc. Why doesn't MNKD simply issue a quick "statement to the press" and or "AF" explaining the situation. Surely someone has made them aware by now. |
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Post by rrtzmd on Nov 11, 2015 11:29:24 GMT -5
Courtesy of Schwab: "MannKind's (NASDAQ: MNKD) TASE financing formally cancelled, according to market reports. UPDATE - According to Israel's Calcalist, regulators in Israel are cancelling MannKind's ability to raise money on the TASE. ETFs were supposed to inject MannKind with 400 million amid its entry into the TA-100 and TA-75 The situation is a barrier between the SEC and MannKind which can prevent the company from raising funds in the manner it intended to, according to Calcalist. The publication noted that "the Israel Securities Authority is investigating the matter but, at the moment there is no decision on the issue." The ISA is opposing Mutual Fund managers from raising funds for two primary reasons: the current security level and liquidity concerns with another offering without the issue being satisfactorily resolved. MannKind shares are down 7 percent after dropping over 15 percent on Tuesday's trading session." This is what I had seen as well, it's confirmed. Unbelievable... But this came from the article I linked to earlier -- or so it seems. I did not get from that article that they had actually cancelled the deal, but that "authorities" were up to something. |
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Post by rrtzmd on Nov 11, 2015 11:25:37 GMT -5
Courtesy of Schwab:
"MannKind's (NASDAQ: MNKD) TASE financing formally cancelled, according to market reports.
UPDATE - According to Israel's Calcalist, regulators in Israel are cancelling MannKind's ability to raise money on the TASE. ETFs were supposed to inject MannKind with 400 million amid its entry into the TA-100 and TA-75
The situation is a barrier between the SEC and MannKind which can prevent the company from raising funds in the manner it intended to, according to Calcalist.
The publication noted that "the Israel Securities Authority is investigating the matter but, at the moment there is no decision on the issue."
The ISA is opposing Mutual Fund managers from raising funds for two primary reasons: the current security level and liquidity concerns with another offering without the issue being satisfactorily resolved.
MannKind shares are down 7 percent after dropping over 15 percent on Tuesday's trading session."
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Post by rrtzmd on Nov 11, 2015 11:21:28 GMT -5
The report is up on Schwab News, I believe it is confirmed. I call this report more short FUD BS. No way you undo moving a security to another exchange when you want to attract additional securities. I don't believe they're "undoing" moving the security. They just not allowing the offering to the ETFs. |
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Post by rrtzmd on Nov 11, 2015 10:33:42 GMT -5
The Israeli drug approval process: drug approval in IsraelThe only thing I see relating to them accepting FDA approval is this: "An abridged registration procedure is available for generic Preparations which already possess marketing authorisations from the US Food and Drug and Administration (FDA) or the European Medicines Agency (EMEA). If no objection is made by the MOH, the registration procedure for these Preparations will be completed within 70 days." I don't think that would apply in afrezza's case. Read the attached on bio similar drugs. Insulin I believe would fall into this category. Perhaps not www.rcip.co.il/en/article/a-new-policy-regarding-the-registration-and-use-of-bio-similar-pharmaceuticals-in-israel/Pretty sure that that wouldn't apply to afrezza. Afrezza contains biosimilar insulin, but it, itself, is not consider biosimilar. |
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Post by rrtzmd on Nov 11, 2015 10:31:13 GMT -5
Here is what Matt told me about the $ 200 million dollar order. A Middle Eastern Prince contacted Al about buying AFREZZA after it is FDA approved. Matt said when a middle eastern Prince called Al, Al got excited and spilled the "beans". Matt made it clear that SNY is in charge of sales now and Matt wasn't sure when and or if that sale was going to happen. Funny but I got the same offer in an email from some Nigerian guy the other day. |
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Post by rrtzmd on Nov 11, 2015 10:26:07 GMT -5
There's this article: from "calcalist"But that doesn't say the listing has actually been cancelled. |
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Post by rrtzmd on Nov 11, 2015 10:22:12 GMT -5
There were a couple of pretty critical articles on "calcalist" yesterday. One of them -- as I recall -- was hinting that something was up with regulators over there.
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Post by rrtzmd on Nov 11, 2015 9:42:00 GMT -5
I have not seen any published comment others than message board speculation about an order from Israel. I would not surprise me since Mann Institute is developing drugs in Israel with their partnership with Israel's Technion. Mann has been a huge supporter of the Technion which is responsible a lot of medical devices and new medicines. From sanofi Israel. Ready for Israel orders. They accept FDA approval The Israeli drug approval process: drug approval in IsraelThe only thing I see relating to them accepting FDA approval is this: "An abridged registration procedure is available for generic Preparations which already possess marketing authorisations from the US Food and Drug and Administration (FDA) or the European Medicines Agency (EMEA). If no objection is made by the MOH, the registration procedure for these Preparations will be completed within 70 days." I don't think that would apply in afrezza's case. |
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Post by rrtzmd on Nov 11, 2015 9:32:47 GMT -5
4% of lives covered by insurance and no change for months. Certainly not where the $122M SNY spent. 122 million would pay for over 1000 reps full time for a year and still leave significant room for many dinners and advertising. Taken from a $ point of view Sanofi is really doing something significant. No obvious results though? Anyone has any insights on this kind of spending in a relatively short time frame? Unfortunately, that's all investors are left with -- speculating about how SNY spent the money. Evidently, MNKD won't reveal or is forbidden from revealing how money is being distributed otherwise they surely would use it to bolster their claims that various issues -- spirometry, third party payors, required trials, etc -- are being addressed. |
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Post by rrtzmd on Nov 10, 2015 20:53:11 GMT -5
Basically it all rests one reading the intentions of Sanofi. The 8000 patient safety study which should be finalized April 30th with the FDA could be an interesting financial 'spending opportunity' to look at. I don't know how much it will cost or how they will structure it but if the FDA insists on a truly randomized 5 year trial that is big $. Maybe they just mean case controlled (which is much much cheaper). Agreed Sanofi can't afford to have a 2nd public sandbagging fiasco on their hands though. Details of the safety study: "Conduct a 5-year, randomized, controlled trial in 8,000-10,000 patients with type 2 diabetes to assess the serious potential risk of pulmonary malignancy with Afrezza use. The primary objective of the trial should be to compare the incidence of pulmonary malignancy observed with Afrezza to that observed in the standard of care control group. Secondary endpoints should include mortality due to pulmonary malignancy and all-cause mortality. Randomization to Afrezza or standard of care should be 1 to 1. The patient population should be enriched with respect to lung cancer risk (i.e., predicted incidence of no less than 200/100,000 patient-year). The potential for detection bias should be adequately addressed in the trial design. Subjects who discontinue randomized intervention due to lack of efficacy or tolerability issues should continue to be followed for the outcomes of interest and prospective measures to encourage subject retention and capture outcomes in patients who withdraw or are lost to follow-up should be in place. Glucose control and glycemic rescue should be per standard of care. The trial must also include an assessment of cardiovascular risk based on prospectively defined, collected and independently adjudicated major adverse cardiovascular events or MACE (i.e., cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke). Also include as part of the trial a substudy (also with 1 to 1 randomization to either Afrezza or standard or care) to evaluate the long-term effect of Afrezza on pulmonary function. Patients in the substudy should have pulmonary function tests at baseline and every 6 months until end of treatment. The timetable you submitted on June 23, 2014 , states that you will conduct this trial according to the following schedule: Final Protocol Submission: April 2015 Trial Completion: April 2023 Final Report Submission: December 2023" That's the first time I noticed that the safety trial was restricted to type 2 patients. Why? Do they think type 1s are immune to cancer? |
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Post by rrtzmd on Nov 10, 2015 20:44:10 GMT -5
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Post by rrtzmd on Nov 10, 2015 20:28:33 GMT -5
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