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Post by slugworth008 on Dec 19, 2018 0:09:22 GMT -5
Are we sure inhaled products work the same in the southern hemisphere; consider the Coriolis effect... Coriolis effect - Ah yes, I had forgotten about that one. That's different from the Corleone effect right?
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Post by babaoriley on Dec 19, 2018 1:47:26 GMT -5
Different in that the Corleone effect is far more powerful, however, both can lead to circling the drain.
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Post by lakers on Jan 11, 2019 18:11:28 GMT -5
MC on 12/7/18: “We are awaiting feedback from Brazil and I have stated Canada could be filed in 1H19. Mexico is not clear bc the administration and rules just changed so once we get an update I will share more.“
We are due for some news anyday now.
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Post by buyitonsale on Jan 11, 2019 18:25:47 GMT -5
ER in February per MC.
Brazil news and profitable Q4 release are within 45 days.
Knock, knock...
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Post by lakers on Jan 12, 2019 2:31:55 GMT -5
May 2nd 2018 Documents submitted to CVM » Notice to the Market - Inhaler Afrezza approval by ANVISA* BIOMM S.A. Public Company CNPJ / MF No. 04.752.991 / 0001-10 NIRE No. 31.300.016.510 NOTICE TO THE MARKET In compliance with article 12 of CVM Instruction 358 of January 3, 2002, BIOMM SA ("Company"), as amended, hereby informs its shareholders, the market in general and other , according to Resolution No. 1,071 of April 26, 2018, published in the Official Gazette of the Federal Government of No 82, of Monday, April 30, 2018, the National Agency of Sanitary Surveillance - ANVISA, the Afrezza inhaler ®. This is an important step for the launch of Afrezza® in Brazil, as the Company will be responsible for the promotion, distribution and sale, exclusively, throughout the country. The next step is the approval of the final product registration that is under analysis at ANVISA. Afrezza® is the only inhalable insulin available on the market and is already approved in the United States by the local FDA. The Company will keep its shareholders and the market in general informed on the subject matter of this announcement to the market in case of future relevant information. Belo Horizonte, May 2, 2018. BIOMM S.A. Douglas de Carvalho Lopes Investor Relations Officer translate.google.com/#view=home&op=translate&sl=auto&tl=en&text=BIOMM%20S.A.%0ACompanhia%20Aberta%0ACNPJ%2FMF%20no%2004.752.991%2F0001-10%20NIRE%20no%2031.300.016.510%0ACOMUNICADO%20AO%20MERCADO%0AA%20BIOMM%20S.A.%20(“Companhia”)%2C%20em%20atendimento%20ao%20disposto%20no%20artigo%2012%20da%20Instrução%20da%20Comissão%20de%20Valores%20Mobiliários%20no%20358%2C%20de%2003%20de%20janeiro%20de%202002%2C%20conforme%20alterada%2C%20vem%20comunicar%20aos%20seus%20acionistas%2C%20ao%20mercado%20em%20geral%20e%20demais%20interessados%20que%2C%20conforme%20resolução%20no%201.071%2C%20de%2026%20de%20abril%20de%202018%2C%20publicada%20no%20Diário%20Oficial%20da%20União%20de%20no%2082%2C%20de%20segunda-feira%2C%2030%20de%20abril%20de%202018%2C%20foi%20aprovado%2C%20pela%20Agência%20Nacional%20de%20Vigilância%20Sanitária%20–%20ANVISA%2C%20o%20inalador%20do%20Afrezza®.%0AEste%20é%20um%20passo%20importante%20para%20o%20lançamento%20do%20Afrezza®%20no%20Brasil%2C%20uma%20vez%20que%20a%20Companhia%20será%20a%20responsável%20pela%20promoção%2C%20distribuição%20e%20venda%2C%20com%20exclusividade%2C%20em%20todo%20o%20território%20nacional.%20O%20próximo%20passo%20é%20a%20aprovação%20do%20registro%20final%20do%20produto%20que%20se%20encontra%20em%20análise%20na%20ANVISA.%0AO%20Afrezza®%20é%20a%20única%20insulina%20inalável%20dispon%C3%ADvel%20no%20mercado%20e%20que%20já%20é%20aprovada%20nos%20Estados%20Unidos%20da%20América%20pela%20agência%20regulatória%20local%20FDA.%0AA%20Companhia%20manterá%20seus%20acionistas%20e%20o%20mercado%20em%20geral%20informados%20sobre%20o%20tema%20objeto%20deste%20comunicado%20ao%20mercado%20em%20caso%20de%20futuras%20informações%20relevantes.%0ABelo%20Horizonte%2C%2002%20de%20maio%20de%202018.%0ABIOMM%20S.A.%0ADouglas%20de%20Carvalho%20Lopes%20Diretor%20de%20Relação%20com%20Investidoresir.biomm.com/default_download.asp?NArquivo=(Biomm)%20Comunicado%20ao%20Mercado%20-%20Aprovacao%20Aparelho%20Inalac%E3o%20Afrezza.pdf&arquivo=6A036E0F-4535-4058-9200-DCD5F364E49C
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Post by morfu on Jan 12, 2019 12:34:06 GMT -5
May 2nd 2018 Documents submitted to CVM » Notice to the Market - Inhaler Afrezza approval by ANVISA* BIOMM S.A. Public Company CNPJ / MF No. 04.752.991 / 0001-10 NIRE No. 31.300.016.510 NOTICE TO THE MARKET In compliance with article 12 of CVM Instruction 358 of January 3, 2002, BIOMM SA ("Company"), as amended, hereby informs its shareholders, the market in general and other , according to Resolution No. 1,071 of April 26, 2018, published in the Official Gazette of the Federal Government of No 82, of Monday, April 30, 2018, the National Agency of Sanitary Surveillance - ANVISA, the Afrezza inhaler ®. This is an important step for the launch of Afrezza® in Brazil, as the Company will be responsible for the promotion, distribution and sale, exclusively, throughout the country. The next step is the approval of the final product registration that is under analysis at ANVISA. Afrezza® is the only inhalable insulin available on the market and is already approved in the United States by the local FDA. The Company will keep its shareholders and the market in general informed on the subject matter of this announcement to the market in case of future relevant information. Belo Horizonte, May 2, 2018. BIOMM S.A. Douglas de Carvalho Lopes Investor Relations Officer translate.google.com/#view=home&op=translate&sl=auto&tl=en&text=BIOMM%20S.A.%0ACompanhia%20Aberta%0ACNPJ%2FMF%20no%2004.752.991%2F0001-10%20NIRE%20no%2031.300.016.510%0ACOMUNICADO%20AO%20MERCADO%0AA%20BIOMM%20S.A.%20(“Companhia”)%2C%20em%20atendimento%20ao%20disposto%20no%20artigo%2012%20da%20Instrução%20da%20Comissão%20de%20Valores%20Mobiliários%20no%20358%2C%20de%2003%20de%20janeiro%20de%202002%2C%20conforme%20alterada%2C%20vem%20comunicar%20aos%20seus%20acionistas%2C%20ao%20mercado%20em%20geral%20e%20demais%20interessados%20que%2C%20conforme%20resolução%20no%201.071%2C%20de%2026%20de%20abril%20de%202018%2C%20publicada%20no%20Diário%20Oficial%20da%20União%20de%20no%2082%2C%20de%20segunda-feira%2C%2030%20de%20abril%20de%202018%2C%20foi%20aprovado%2C%20pela%20Agência%20Nacional%20de%20Vigilância%20Sanitária%20–%20ANVISA%2C%20o%20inalador%20do%20Afrezza®.%0AEste%20é%20um%20passo%20importante%20para%20o%20lançamento%20do%20Afrezza®%20no%20Brasil%2C%20uma%20vez%20que%20a%20Companhia%20será%20a%20responsável%20pela%20promoção%2C%20distribuição%20e%20venda%2C%20com%20exclusividade%2C%20em%20todo%20o%20território%20nacional.%20O%20próximo%20passo%20é%20a%20aprovação%20do%20registro%20final%20do%20produto%20que%20se%20encontra%20em%20análise%20na%20ANVISA.%0AO%20Afrezza®%20é%20a%20única%20insulina%20inalável%20dispon%C3%ADvel%20no%20mercado%20e%20que%20já%20é%20aprovada%20nos%20Estados%20Unidos%20da%20América%20pela%20agência%20regulatória%20local%20FDA.%0AA%20Companhia%20manterá%20seus%20acionistas%20e%20o%20mercado%20em%20geral%20informados%20sobre%20o%20tema%20objeto%20deste%20comunicado%20ao%20mercado%20em%20caso%20de%20futuras%20informações%20relevantes.%0ABelo%20Horizonte%2C%2002%20de%20maio%20de%202018.%0ABIOMM%20S.A.%0ADouglas%20de%20Carvalho%20Lopes%20Diretor%20de%20Relação%20com%20Investidoresir.biomm.com/default_download.asp?NArquivo=(Biomm)%20Comunicado%20ao%20Mercado%20-%20Aprovacao%20Aparelho%20Inalac%E3o%20Afrezza.pdf&arquivo=6A036E0F-4535-4058-9200-DCD5F364E49CNot quite on topic, but its keeps on bugging me.. Mike and management must have known about this happening some time soon. And it is likely to affect the share price in a good way. So again, the question, why sell out 20% of the company before Christmas, there hasn`t been any decent answer ..
Like I said in the Good CC thread: "Well.. I see a lot of how it feel to run a company without to worry about money problems and I understand that! Also, "[..]I mean, we were up down, up down and so being able to price that offering at about 8.5% discount for about 15% dilution with a very fair price that we thought balanced shareholder value and making sure we funded 2019[..]" sound reasonable.. unless of course you happen to think (like me), that the current pricing is nowhere near the real value!
The shorts control the share price right now! In this situation anyone who sells shares feeds the shorts and gives money away! (and as I pointed out repeatedly, in case of the offering it was the shareholders money)
The luxury of pretending to have no money problems for 18months came as a steep price and the management is not paying the bill! There were smarter ways to raise money if it was needed at all, Mike sold out!"
I think more and more we need a better answer than was has been said so far!
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Post by akemp3000 on Jan 12, 2019 13:33:40 GMT -5
If Biomm receives the approval for Afrezza now, will this result in an initial product order? If so, would this cause a one-time jump in one weekly scripts report or would this be off record from the U.S. scripts reporting?
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Post by golfeveryday on Jan 12, 2019 13:50:24 GMT -5
If Biomm receives the approval for Afrezza now, will this result in an initial product order? If so, would this cause a one-time jump in one weekly scripts report or would this be off record from the U.S. scripts reporting? it wouldn’t have anything to do with weekly scrip sales, just revenue from sale of insulin I believe.
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Post by mnholdem on Jan 12, 2019 14:50:12 GMT -5
Revenue from sales of Afrezza as a finished good, not simply insulin. The Agreement states that MannKind will be the manufacturer and will be supplying the packaged product to Biomm S.A. for distribution in Brazil. Purchase orders from Biomm will be reported as international sales, so the number of scripts will be unknown unless you subscribe to an international reporting service.
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Post by mannmade on Jan 12, 2019 15:23:21 GMT -5
Am guessing we should hear sometime this quarter as MC had previously mentioned was expecting last quarter.
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Post by mytakeonit on Jan 12, 2019 15:38:59 GMT -5
In any case ... revenue will be going up.
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Post by agedhippie on Jan 12, 2019 17:19:06 GMT -5
Not quite on topic, but its keeps on bugging me.. Mike and management must have known about this happening some time soon. And it is likely to affect the share price in a good way. So again, the question, why sell out 20% of the company before Christmas, there hasn`t been any decent answer ..
...
Of course they knew about this, it was announce back in May when it happened it was even discussed on this board ( An important step towards the launch of Afrezza® in Brazil). Lakers just dredged up that same old PR, it's not news. This was discussed in the last earnings call and a target date for approval was given as Q4. That didn't happen however they said in the latest CC that they expected approval imminently. I doubt there will be much of a price bump since this should already have been priced in for nearly a year now. That could change if BIOMM start placing regular large orders and depending on revenue generated.
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Post by morfu on Jan 13, 2019 11:39:41 GMT -5
Not quite on topic, but its keeps on bugging me.. Mike and management must have known about this happening some time soon. And it is likely to affect the share price in a good way. So again, the question, why sell out 20% of the company before Christmas, there hasn`t been any decent answer ..
...
Of course they knew about this, it was announce back in May when it happened it was even discussed on this board ( An important step towards the launch of Afrezza® in Brazil). Lakers just dredged up that same old PR, it's not news. This was discussed in the last earnings call and a target date for approval was given as Q4. That didn't happen however they said in the latest CC that they expected approval imminently. I doubt there will be much of a price bump since this should already have been priced in for nearly a year now. That could change if BIOMM start placing regular large orders and depending on revenue generated. I apologize, but again I strongly disagree with what you are writing! They knew last May, that this approval would come on Jan 11th next year!? And something that did NOT happen in Q4 as announced, was already factored into the price? I grant you, that most investors knew that this is likely to happen, but the actual approval is a different animal!
In my opinion nothing is factored into the current share price! It's just heavily suppressed by the shorts, but Mike's Christmas present (which we are paying for) will run out soon enough. A couple of years back an estimate was posted in a thread here (confusing basal and mealtime insulin), that a 1% USA market penetration would generate about 1$ EPS. And that was pre-reverse split.. In my opinion, this is about the only thing you should to factor into the current share price..
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Post by agedhippie on Jan 13, 2019 11:59:41 GMT -5
Of course they knew about this, it was announce back in May when it happened it was even discussed on this board ( An important step towards the launch of Afrezza® in Brazil). Lakers just dredged up that same old PR, it's not news. This was discussed in the last earnings call and a target date for approval was given as Q4. That didn't happen however they said in the latest CC that they expected approval imminently. I doubt there will be much of a price bump since this should already have been priced in for nearly a year now. That could change if BIOMM start placing regular large orders and depending on revenue generated. I apologize, but again I strongly disagree with what you are writing! They knew last May, that this approval would come on Jan 11th next year!? And something that did NOT happen in Q4 as announced, was already factored into the price? I grant you, that most investors knew that this is likely to happen, but the actual approval is a different animal!
In my opinion nothing is factored into the current share price! It's just heavily suppressed by the shorts, but Mike's Christmas present (which we paying for) will run out soon enough. A couple of years back an estimate was posted in a thread here (confusing basal and mealtime insulin), that a 1% USA market penetration would generate about 1$ EPS. And that was pre-reverse split.. In my opinion, this is about the only thing you should to factor into the current share price.. I am not sure why you think Jan 11th is the significant, Afrezza is not approved yet. If you go back to the original discussion I provided the link for the estimate was 9 months which would place it end of this month or early February so things are exactly where they were expected to be. Equity pricing is partially based on future prospects hence the buy the rumor, sell the news mantra. The market takes a guess at the implications of things and adjusts it projection and so it's price accordingly.
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Post by travis1953 on Jan 13, 2019 13:31:13 GMT -5
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