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Post by lakers on Nov 7, 2015 12:00:05 GMT -5
moodle.univ-lille2.fr/pluginfile.php/89852/mod_resource/content/0/AFREZZA%20lavenir%20dune%20insuline%20inhalée.pptxLooking forward to 2016: $25M bonus for Qualifying Sny insulin for Afrezza And $30M bonus for EMA Approval And $20M bonus for Japan Approval EU, Middle East Launch "You have to ask Sanofi about that" 2 more indicators: oncology, antiemetic, lung injury 2 Wild Cards. It's all up to Al, now that he is 90. He'd want to leave a great legacy and long lasting franchises to carry on... A majority of great men think alike...Simple 101 psyc... 2016 is shaping up to be an exciting year for us.
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Post by dreamboatcruise on Nov 7, 2015 13:27:20 GMT -5
What is a regulatory seminar? This was like a case study at the university? I thought this might have been some official document in the EU approval process until I came to slide 21. Loved that  It's a really good presentation... though on the conclusion slide is the worrying fact that they list the following as a potential "threat"... " Need of phase IV study for European approval?" This was presented in March. I wonder if the clamp study might be what they are referring to as phase IV. Hard to tell when all those things you list will happen, but I am quite confident that Al intended Mannkind to be a lasting legacy. |
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Post by cjc04 on Nov 7, 2015 14:59:29 GMT -5
As nice as the presentation is, I'll bet it was more exciting to read in March when it first came out.... I took it as a stiff reminder that we've been approved and partnered for over a year and not much has happened.
Slide 113 was was interesting, seeing how all we have is to grasp at straws,,,,, when referring to EU approval it says "submitted directly to the agency"....... Doesn't necessarily mean in the past tense, but......
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Post by southd44 on Nov 16, 2015 10:36:42 GMT -5
Anyone think the "insulin Human" mentioned in today's EMA CHMP agenda could be Afrezza?
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Post by harryx1 on Nov 16, 2015 10:50:58 GMT -5
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Post by bradleysbest on Nov 16, 2015 11:00:01 GMT -5
Don't know but sure hope so! We could use some good news.....
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Post by Chris-C on Nov 16, 2015 11:02:49 GMT -5
Harryx1
It would be great if Afrezza is the application being considered. Previous discussions on this board about this item have tended to conclude that it is not. As memory serves, I don't think management has been asked if an application has yet been submitted to EMA by SNY. I imagine they would refer such questions directly to SNY, since it is responsible under the agreement for such regulatory changes/approvals. Also, as best I recall, according to the usual approval timeline, an application to EMA would have been made very shortly after the agreement was between SNY and MNKD was announced; thus casting doubt on the likelihood this is Afrezza. Let's keep our fingers crossed!
Regards,
Chris C
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Post by doodyfree on Nov 16, 2015 11:05:14 GMT -5
it would explain the recent sub-zone application
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Post by jeremg on Nov 16, 2015 11:13:25 GMT -5
003858 - is this the same number we've seen in previous "insulin human" EMA information? Everytime this pops up it seems to die down with a big "?". For one thing, why wouldn't we be told if an application for EMA approval was truly submitted, that would seem to be very significant "material news" if true. I am very doubtful this "human insulin" is actually Afrezza, SNY's recent behavior would not lend a lot of reason to believe they are actively pursuing foreign markets.
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Post by harryx1 on Nov 16, 2015 11:13:51 GMT -5
Chris-C,
I agree we don't know if it is or not. But what other insulin human is out there that's not approved by EMA?
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Post by jeremg on Nov 16, 2015 11:16:52 GMT -5
Chris-C, I agree we don't know if it is or not. But what other insulin human is out there that's not approved by EMA? It could be a new generic (Insulin glargine etc.) or "Insuman" seeking to enter the European market(?) |
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Post by suebeeee1 on Nov 16, 2015 11:25:43 GMT -5
Chris-C, I agree we don't know if it is or not. But what other insulin human is out there that's not approved by EMA? It could be a new generic (Insulin glargine etc.) or "Insuman" seeking to enter the European market(?) No, it is written as insulin HUMAN. Insulin glargine or insurance would be marked as such. Unfortunately this is the initial application. The waiting game begins...again. |
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Post by cathode on Nov 16, 2015 11:30:49 GMT -5
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Post by suebeeee1 on Nov 16, 2015 11:41:41 GMT -5
Until we get affirmative word from MNKD or SNY, we are left to guess. Pathetic, huh?
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Post by jeremg on Nov 16, 2015 11:41:50 GMT -5
It could be a new generic (Insulin glargine etc.) or "Insuman" seeking to enter the European market(?) No, it is written as insulin HUMAN. Insulin glargine or insurance would be marked as such. Unfortunately this is the initial application. The waiting game begins...again. So this is a different entity from the last "insulin human" applications we've seen pop up on EMA reviews? How can you tell its an "initial application"? If this is Afrezza, whether its the first step in the process or the last, it would be a very encouraging sign that SNY would seek to enter another market with MNKD. |
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