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Post by awesomo on Jun 3, 2019 11:43:04 GMT -5
Now we can wait for the other shoe to drop, namely, the financials related to the MannKind-Biomm partnership, aka upfront payment and royalties. Wouldn't any upfront payments have occurred on the deal signing and/or approval? I'd like to have more guaranteed money, but I'm not sure what upfront payments could occur at this point.
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Post by boca1girl on Jun 3, 2019 12:14:24 GMT -5
Now we can wait for the other shoe to drop, namely, the financials related to the MannKind-Biomm partnership, aka upfront payment and royalties. Wouldn't any upfront payments have occurred on the deal signing and/or approval? I'd like to have more guaranteed money, but I'm not sure what upfront payments could occur at this point. From what I remember, no financial terms were disclosed when we partnered with BIOMM. Maybe there will be milestone payment to MNKD as a result of the approval, maybe not.
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Post by buyitonsale on Jun 3, 2019 12:16:37 GMT -5
There was no upfront money in the original agreement as opposed to India, so I think that it’s unlikely.
As far as royalties, MNKD owns product, it’s not a licensing agreement, MNKD will direct sell and ship to Biomm at negotiated price and they will in turn market and sell through their channels.
I think it’s s clean arrangement and easy to administer, similar to US revenue model.
IMO
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Post by ktim on Jun 3, 2019 12:27:18 GMT -5
They should have the complete mnkd website in the most commonly spoken language(s) of every country Afrezza is sold in. That includes Spanish here in the states. It may be that Biomm will be responsible for the website, given that regulatory oversight is part of the task of running a pharma website and I believe Biomm is responsible for regulatory issues (and marketing) in Brazil. I'd assume they create one with their own URL, e.g. Afrezza.br
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Post by harryx1 on Jun 3, 2019 12:54:34 GMT -5
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Post by uvula on Jun 3, 2019 13:22:42 GMT -5
Now, launch in Brazil isn't until December. But, how long before people start complaining about the sluggish sales in Brazil? Anyone want to start a pool? O.K. I'm setting my egg timer, though. I'm looking for a list of Brazilian holidays so that I can point out short work weeks whenever weekly script numbers are low.
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Post by slugworth008 on Jun 3, 2019 14:17:44 GMT -5
Now, launch in Brazil isn't until December. But, how long before people start complaining about the sluggish sales in Brazil? Anyone want to start a pool? O.K. I'm setting my egg timer, though. I'm looking for a list of Brazilian holidays so that I can point out short work weeks whenever weekly script numbers are low. ROTFLMAO
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Post by Chris-C on Jun 3, 2019 14:49:19 GMT -5
I'm going to overlook the pervasive cynicism on the board and offer congratulations to Mike C and his staff for what we all hope will be the first of many approvals in other countries. This is a positive development for the Brazilians with diabetes and for the company. It did not happen without hard work.
I also want to offer a positive shout out to Harryx1 of this board, who consistently discovers and shares information that is hard to find, useful and encouraging. Thanks for your work!
Good luck to all longs!
Chris-C
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Post by humann on Jun 3, 2019 15:11:15 GMT -5
I second, Chris-C. The bottom line for me is that of the three alternatives: approval, disapproval or prolonged uncertainty about approval, this is definitely the desired outcome, so I'm counting this a positive checkmark off the list of future uncertainties. Still long!
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Post by harryx1 on Jun 3, 2019 17:38:08 GMT -5
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Post by mnkdfann on Jun 3, 2019 17:47:02 GMT -5
Translation of medicafitdiabetica's comment:
I made a summary of this news! Read it calmly, but the excitement is inevitable, right? (I.e. . Afrezza®, an ultra-rapid inhaled insulin for pre-meal use, was registered today by ANVISA. . Commercialized in the United States since its approval by the FDA in 2015, it will be available in Brazil until the fourth quarter of this year. . Supplied with a small, discreet, easy-to-use inhaler, it is given at the beginning of the meal. Afrezza®️ dissolves rapidly after inhalation into the lung and immediately reaches the bloodstream. Maximum insulin levels are achieved within 12 to 15 minutes after administration and decline by approximately 180 minutes. . In addition, Afrezza®️ has, among all the insulins available on the market, the action profile that most resembles physiological insulin, since the absorption pathway (lung) and form (insulin monomers) allow absorption and action of insulin more quickly than the others. . It is worth noting that Afrezza® should be used in combination with long acting insulin in patients with type 1 diabetes. Afrezza® is not recommended for the treatment of diabetic ketoacidosis and for patients who smoke. It has not yet been tested on people under 18 years of age. . The main limitation is the low range of dosages available. There are only three presentations: 4, 8 or 12 units, while injectable insulins are offered in doses of 1 unit, which allows more combination and personalization. . It is not yet possible to estimate how much the product will cost in Brazil. In the United States, the lowest dose, 4 units, costs $ 3.80, or about $ 15.
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Post by celo on Jun 3, 2019 23:09:21 GMT -5
Are advertisement rules for medications different in Brazil than the United States? Wheres the black box warnings? Wheres the FDA police to not allow advertising? Instagram, Facebook and other websites do not stop at a country border. Can Mannkind now put out a lot of advertising (in Portuguese) without worrying about being slapped on the wrist by the FDA? Maybe they need to produce some ads for the English speaking Brazilians.
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Post by mnkdfann on Jun 3, 2019 23:22:34 GMT -5
Are advertisement rules for medications different in Brazil than the United States? Wheres the black box warnings? Wheres the FDA police to not allow advertising? Instagram, Facebook and other websites do not stop at a country border. Can Mannkind now put out a lot of advertising (in Portuguese) without worrying about being slapped on the wrist by the FDA? Maybe they need to produce some ads for the English speaking Brazilians. According to what I have seen and read, the U.S. is one of the nations that allows the freest advertising (direct to consumer) of pharmaceutical drugs. Pharmas are not allowed to advertise (direct to consumer) at all, in most nations. E.g., see: en.wikipedia.org/wiki/Direct-to-consumer_advertisingBrazil appears to be more restrictive than the U.S.: "In 2008 a new resolution from ANVISA (Control Agency for Sanitary Vigilance), Resolution 96 from December 17 was released, with focus on medication advertisements. It allows direct-to-consumer advertising of non-prescription medication, with restrictions on the type of drug and words and images that can be used, among other things. Advertisements for prescription medications can only appear in scientific, medical, or health professional journals." Afrezza being prescription, don't expect to see much in the way of advertising for it in Brazil.
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Post by harryx1 on Jun 4, 2019 9:24:16 GMT -5
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Post by kite on Jun 4, 2019 10:30:28 GMT -5
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