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Post by obamayoumama on Oct 13, 2014 18:56:06 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.
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Post by mrhaigs on Oct 13, 2014 21:52:29 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. Yea, I think the same prince contacted me too. He wanted me to forward him $10,000 to gain access to a safety deposit box filled with gold bars and ancient rubies that we are going to split. Can't wait for my riches!
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Post by jurystillout on Oct 14, 2014 17:06:36 GMT -5
Very good point, if SNY had committed to a volume of sales greater than $800M, MNKD would be foolish to not prepare to fill the order. I think it would be safe to say that if SNY committed to any volume of sales it would be less than $800M, how much lower ?? Is the commitment volume tiered??? I only hope that MNKD insisted on a committed volume of sales to be identified in the partnership contract, this is business 101 when agreeing to an exclusive sales agreement. Does this reflect on the enthusiasm SNY has for this product and is it a window for what we can expect from SNY's marketing plans? The intentions of SNY is the biggest question / concern for me. It is for me, too! So many people on the YMB are screaming about MNKD management, but it's SNY we should be fearing from. If you really think about it, Mnkd for the most part has been reduced to running 1 production facility in this deal. What elsr are they responsible for? That's why I think this is step 1 for an eventual buyout. As far as the Israel comment, it was made about a week after the agreement by the SNY VP of Israeli marketing. Finally, the fact that as far as the public knows, including us, the best sales we could do based on production is at $800M. Don't think that causes people to jump in a buy yet. I still feel the responsibility to communicate with and protect the shareholder interests lands squarely on Mannkind managements shoulders, I didn't purchase shares in SNY, I bought MNKD stock. If MNKD sells that's okay with me, if they don't that's okay too, my money is going to be invested somewhere,it just has to be somewhere that is positively multiplying it. I can't make good investment decisions without good information and I don't feel like Mannkind management is providing that right now. I really hate it when investing starts to feel like gambling. All the answers to my questions are written in the partnership contract however we will never see full disclosure.
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Post by kc on Nov 10, 2015 21:55:59 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. View AttachmentView AttachmentReady for Israel orders. They accept FDA approval
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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 dreamboatcruise on Nov 11, 2015 9:58:16 GMT -5
I am the question man! I understood Matt to say that they were going to stay at 3 lines until EMA. Now I am not sure if he meant the submittal or the approval, but I don't understand capping sales at $800M. One of the first things SNY said was Israel was good for $200M. The lines take apprx. 6 months from ordering to operation from my understanding. They also got $150M recently and will get another $75M in Nov. Wouldn't it make sense to start adding ASAP? Maybe I am overly optimistic, but my biggest concern is meeting demand. Do they think "A" will only do $600M to $800M in the first year plus+ in the USA? And even if they are right, wouldn't backup production capacity make sense? We know this is a great product and I think (MY opinion) the demand will go viral very quickly. So why not spend $10M of that money to increase production that you know you will need eventually? What am I missing? Thet spend over a Billion developing the drug, but don't want to spend a few million for back-up production? TIA Yes, perhaps a (huge) bit overly. I think you are missing that 3 lines is way more production capacity than needed in the foreseeable future, already providing huge back-up production capacity. BTW... The Middle East is notorious for having big deals that are talked about and never happen. I have direct experience to draw upon to support that. And anybody that is anybody in business over there seems to be a prince. How many siblings does the current Saudi king have... not sure anyone has even counted them all. Now is not the time to spend any more on production capacity. Now is the time to let the stock room supply of pens deplete and only reorder when there are none left in order to preserve capital... said with only partial sarcasm.
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Post by kc on Nov 11, 2015 10:08:02 GMT -5
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. 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/
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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 10:33:42 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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