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Post by charlespk on Aug 27, 2015 17:54:14 GMT -5
Agree , timing is crucial, I meant to state that as well , but did not post .
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Post by rockstarrick on Aug 27, 2015 18:26:21 GMT -5
We are literally grasping at straws at this point for any good news, aren't we? I wonder if there is a board out there where people are saying as part of the short thesis - "Look at how delusional stockholders in MNKD are - they believe that Afrezza is being sold in other countries without either SNY or MNKD announcing it." No doubt, it seems that these articles have been shuffled before published. I checked to see if trials were conducted in Brazil for Exhubra and they were. I'm sure some of the bashers were kept busy on this one @ Yahzoo. Oh well, still looking forward to the Penthouse Party. Peace Out Three trials (108, 109 and 110) were conducted in North America and two trials (1001 and 1002) were conducted in Europe, South America, the Middle East and Africa (Table 3.1.2.1.1). Three were of 24-week duration and two of 12-week duration; generally FDA recommends 24 to 26- week duration for a trial to assess Type 2 antidiabetic drugs. Table 3.1.2.1.1 Studies in patients with Type 2 diabetes Study Dates Locations (# centers) Duration of randomized treatment Total # of patients randomized 108 9/99 to 12/00 US (38) Canada (11) 24 weeks 299 109 6/99 to 9/00 US (40) Canada (12) 12 weeks 309 110 10/99 to 3/01 US (40) 12 weeks 145 1001 2/00 to 12/01 Europe (43) Scandinavia (13) UK (6) Israel (4) Brazil (4) South Africa (3) 24 weeks 427 1002 3/00 to 5/02 Europe (44) Scandinavia (13) UK (7) Israel (5) Brazil (5) South Africa (3) 24 weeks 476
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Post by nylefty on Aug 27, 2015 18:43:27 GMT -5
We are literally grasping at straws at this point for any good news, aren't we? I wonder if there is a board out there where people are saying as part of the short thesis - "Look at how delusional stockholders in MNKD are - they believe that Afrezza is being sold in other countries without either SNY or MNKD announcing it." I (literally) groaned when I saw this post on StockTwits: snrlvr $MNKD How can Afrezza be selling in South America and NOT A WORD ABOUT IT FROM MGMNT? I am sorry but that upsets me! Bullish
I responded by saying there had been no word about it from management because it was not true.
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Post by charlespk on Aug 27, 2015 18:48:56 GMT -5
Ok , as promised , here it goes.
Apenas a Pfizer tem pesquisas nessa linha?
Dra. Vivian Ellinger - Não, outros laboratórios estão pesquisando insulina inalável, alguns já em fase bem avançada.
O Gel para administração intranasal da insulina é uma outra forma de administração em estudo.
A insulina Exubera será disponibilizada apenas em blisters de 1mg e 3mg. Quando for necessária a administração de doses diferenciadas, será complicado para o usuário fazer esse cálculo?
O cálculo deve considerar que o blister de 1mg corresponde a três unidades internacionais de insulina e 3mg correspondem a 8 unidades internacionais.
Mas o que se espera tanto do médico quanto do paciente é que ambos passem a pensar na dosagem em miligramas e esqueçam as “unidades internacionais”. Essa é uma nova forma de se dosar e de se ajustar a dose da insulina.
*A insulina em questão teve sua comercialização interrompida, no Brasil, conforme comunicado publicado aqui.
Translation:
No , other laboratories are investigating inhaled insulin , some are in an advanced phase.
or a gel for intranasal insulin administration .
Exubera insulin is is administered in blisters of 1 mg to 3 mg , with one mg corresponding to 3 IU of insulin and 3 mg corresponding to 8 IU.
* the insulin in question has been interrupted comercially , as seen in the public communication . If you click at the end where it says conforme comunicado publicado aqui , you will clearly see the news that Pfizer has stopped Exubera .
This should clarify to our board members that is is about when Exubera was discontinued by Pfizer , and they interviewed the professor .
As much as we all want Afrezza to start selling in other countries , this is clearly about Exubera and when Pfizer discontinued it .
Disclosure , I am about 99.9 % that my translation is correct , and I think this helps stop the confusion , but like I said earlier, Portuguese is not my first language .
Thanks for the opportunity to take a crack at it .
don't worry , the time will come when Afrezza will become a global drug available to diabetics everywhere , we have to be patient
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Post by nylefty on Aug 27, 2015 21:09:52 GMT -5
It seems to me that the interview in question must have been done many months before Exubera was pulled from the market and in fact was done in the same year that Exubera was approved in Brazil.
The interviewee says that it was approved in "June" (presumably in June 2006 and in Brazil, not in the U.S.), "not long after other countries." And she specified the doses of Exubera that would be available in Brazil:
"A insulina Exubera será disponibilizada apenas em blisters de 1mg e 3mg."
"The insulin Exubera will be available only in blister packs containing 1 mg and 3 mg."
I assume that the link to the news that Exubera had been scrapped in October 2007 was added to the article on the website the year after the original interview was posted.
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