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Post by celo on Oct 12, 2017 16:55:39 GMT -5
So where are we in this process? 1 to 2 weeks until filing and then how long until approval for the market? Fast track?
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Post by nemzter on Oct 12, 2017 17:03:39 GMT -5
BIOM3 stock might be a good buy before they make the filing announcement....
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Post by compound26 on Oct 12, 2017 18:21:27 GMT -5
So where are we in this process? 1 to 2 weeks until filing and then how long until approval for the market? Fast track? Here is what the management said about this in the last conference call: Finally on this topic, we announced our international expansion with Brazil, that is on track to file our meeting request by the end of this year and what will next happen is a inspection of our manufacturing facilities will occur and at that point we will be ready to file the application with an expectation of potential approval in late 2018. seekingalpha.com/article/4096149-mannkinds-mnkd-ceo-michael-castagna-q2-2017-results-earnings-call-transcript?part=single
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Post by nadathing on Oct 12, 2017 18:36:50 GMT -5
So where are we in this process? 1 to 2 weeks until filing and then how long until approval for the market? Fast track? Here is what the management said about this in the last conference call: Finally on this topic, we announced our international expansion with Brazil, that is on track to file our meeting request by the end of this year and what will next happen is a inspection of our manufacturing facilities will occur and at that point we will be ready to file the application with an expectation of potential approval in late 2018. seekingalpha.com/article/4096149-mannkinds-mnkd-ceo-michael-castagna-q2-2017-results-earnings-call-transcript?part=singleLate 2018. ay caramba!
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Post by Omega on Oct 12, 2017 22:23:20 GMT -5
BIOM3 stock might be a good buy before they make the filing announcement.... Looks like BIOM3 has been Up ever since the BIOM3 & MNKD Afrezza Distribution Announcement Back on May 31st. Brazil, May 31, 2017 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) and BIOMM SA (BVMF:BIOM3) today announced that they have entered into a supply and distribution agreement for the commercialization of Afrezza® (insulin human) Inhalation Powder in Brazil.
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Post by Deleted on Oct 12, 2017 22:48:42 GMT -5
There has got to be an event that triggers some money up front. How much and when are the biggest questions.
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Post by falconquest on Oct 13, 2017 4:29:14 GMT -5
If your comment is a reference to the native language in Brazil, understand that they speak Portuguese so it would be.... "ah não".
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Post by agedhippie on Oct 13, 2017 10:50:49 GMT -5
BIOM3 stock might be a good buy before they make the filing announcement.... Looks like BIOM3 has been Up ever since the BIOM3 & MNKD Afrezza Distribution Announcement Back on May 31st. Brazil, May 31, 2017 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) and BIOMM SA (BVMF:BIOM3) today announced that they have entered into a supply and distribution agreement for the commercialization of Afrezza® (insulin human) Inhalation Powder in Brazil.More likely that jump was in response to their successful completion of the rights offering to complete the work on their insulin manufacturing plant. Up until that point it wasn't clear they could complete the factory hence the jump when they got the money. Currently BIOMM are buying Regular insulin and NPH from a company in Poland, or will be once the approvals finally arrive (they were filed in January). Approval should not be an issue since the Poland factory is already approved by the regulator but they are still nine months in! Separately BIOMM has also signed a contract to buy the insulin pen bodies for use with the Polish insulin. The summary is that BIOMM are focused on supplying injectable insulin for a big government supply contract. It looks like approval takes a minimum of 9 months.
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Post by lakers on Oct 13, 2017 17:35:34 GMT -5
Biomm SA, formerly Savicevic Participacoes SA, is a Brazil-based company primarily engaged in the biotechnology industry. The Company is principally engaged in the development and licensing of technology for the production of human insulin and other recombinant proteins. The Company’s technology is suitable for the production of therapeutic proteins, which are used in the production of drugs and biopharmaceuticals. The Company’s technology for insulin production is protected by patents in various countries in Europe, Asia, North and South America. In addition, it is active in the development of production process of enzymes that are used in the hydrolysis of biomass and in the manufacture of bio-fuel. As of December 31, 2011, the Company’s subsidiaries were Biomm International Inc, Biomm Middle East Inc and Biomm Russia Ltd.
A Precursor to partnering in UAE, Saudi Arabia, Oman, B, R of BRIC ? Afrezza was trademarked in Russia in 2015, the same year as Mexico, Canada.
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Post by agedhippie on Oct 13, 2017 19:23:56 GMT -5
Biomm SA, formerly Savicevic Participacoes SA, is a Brazil-based company primarily engaged in the biotechnology industry. The Company is principally engaged in the development and licensing of technology for the production of human insulin and other recombinant proteins. The Company’s technology is suitable for the production of therapeutic proteins, which are used in the production of drugs and biopharmaceuticals. The Company’s technology for insulin production is protected by patents in various countries in Europe, Asia, North and South America. In addition, it is active in the development of production process of enzymes that are used in the hydrolysis of biomass and in the manufacture of bio-fuel. As of December 31, 2011, the Company’s subsidiaries were Biomm International Inc, Biomm Middle East Inc and Biomm Russia Ltd. A Precursor to partnering in UAE, Saudi Arabia, Oman, B, R of BRIC ? Afrezza was trademarked in Russia in 2015, the same year as Mexico, Canada. BIOMM Middle East is JV with a Saudi company to establish in insulin manufacturing plant in Saudi Arabia using BIOMM's patent manufacturing process.
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Post by mnkdfann on Dec 13, 2018 20:39:42 GMT -5
Looks like BIOM3 has been Up ever since the BIOM3 & MNKD Afrezza Distribution Announcement Back on May 31st. Brazil, May 31, 2017 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) and BIOMM SA (BVMF:BIOM3) today announced that they have entered into a supply and distribution agreement for the commercialization of Afrezza® (insulin human) Inhalation Powder in Brazil.More likely that jump was in response to their successful completion of the rights offering to complete the work on their insulin manufacturing plant. Up until that point it wasn't clear they could complete the factory hence the jump when they got the money. Whatever the reason was, that pop did not last and Biomm's share price is down to 8 (BRL) and change today. It will be interesting to see if approval squeaks in before the end of 2018 to meet the expectation set over a year ago.
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Post by tw12 on Dec 13, 2018 23:13:45 GMT -5
I was nosing about on the ANVISA website tonight. They are a busy group (e.g. simplified registration of 43,680 new cosmetics in 2017). Here are some stats from their annual report for 2017. They seem to be working on reducing wait times for approval of new drugs... The web site is: portal.anvisa.gov.br/documents/281258/2742545/Folder+-+Results+2017/4aea5387-8a3e-4325-a6f6-3e109533ffb8. YOU CAN FIND ANVISA’S ACTIVITIES REPORTS ON: PORTAL.ANVISA.GOV.BR/RELATORIOS-DE-ATIVIDADESANVISA 2017 BRAZILIAN STATISTICS AT A GLANCE1,063 health products were registered and 776 revalidated403 foods registered 258 new foods, 78 foods with functional properties and 30 foods for children 33 biological products registered 11 for rare diseases and 8 anticancer drugs The drug Spinraza® (nusinersen) was registered in Brazil for the treatment of Spinal Muscular Atrophy 5q (SMA) 3 biosimilar products (trastuzumab, etanercept e glargine insulin) were registered for the first time The 1st medical product made with Cannabis sativa (Mevatyl®) was registered in Brazil, for specific cases Cosmetics and sanitizers784 medicines, biological products and active pharmaceutical ingredients were registered Anvisa reduced waiting times for register and post-register analysis Registration ↓ 55% | Generic and similar drugs ↓ 16% | Innovator drugs Post-registration ↓ 18% | Generic and similar drugs (more complex) ↓ 26% | New drugs (more complex) ↓ 85% | Generic, new and similar (less complex) There was a 36% reduction on the average time to publish such authorizations, from 400 to 255 days1st and 2nd editions of Statistical Pharmaceutical Industry Yearbook were published 292,165 calls were received by the call center Registration 699 cosmetics 1,064 sanitizers Customer services 19,665 demands were answered by phone by the Ombudsman’s Office 88% of problem-solving in the 1st call (Satisfaction Survey 2017) Simplified registration 43,680 new cosmetics 8,218 new low-risc sanitizers. The 2017-2020 Regulatory Agenda was published with 126 priority themesR$ 265.3 million available to states and municipalities for health regulatory actions RDC 183/2017 | Updated rules on inspection and administrative procedures for the concession of GMP certification of health products manufacturers outside Brazil and Mercosul.
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Post by mnkdfann on Dec 13, 2018 23:35:31 GMT -5
I was nosing about on the ANVISA website tonight. They are a busy group (e.g. simplified registration of 43,680 new cosmetics in 2017). Here are some stats from their annual report for 2017. They seem to be working on reducing wait times for approval of new drugs... See also: mnkd.proboards.com/thread/10573/brazils-anvisa-eliminate-backlog-2019
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Post by lakers on Dec 14, 2018 1:52:07 GMT -5
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Post by patten1962 on Dec 14, 2018 2:39:59 GMT -5
I am a little lost. This is from July 11. Did something new happen?
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