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Post by hammer on Nov 17, 2015 15:03:21 GMT -5
Based on the fact that both Mannkind and Sanofi basically have chosen a minimal disclosure attitude towards anything related to marketing and expansion of Afrezza.  Stealth. According to Griffin, toujeo's appeal to Sanofi (aka Snafu-i) may fade as early as Jan. 16. Those folks at Griffin seem to have good insights. Or, maybe I just agree with them.  You found the operative word. STEALTH. We can argue if the application is for Afrezza or not, but its undeniable there exist an EU application for human insulin. Either way its being done by someone and with stealth. |
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Post by james on Nov 17, 2015 15:16:54 GMT -5
If this does turn out to be Afrezza related, it explains a number of critical questions that are circulating, not the list of which is why the safety study has yet to initiate. Of course, the EMA's opinions on study design would be an absolute requirement before initiating that expense. That the FDA required this safety study is itself yet another reason why the EMA approval process absolutely should have been initiated at the earliest opportunity, so as to be able to achieve that input at the right time.
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Post by derek2 on Nov 17, 2015 16:05:00 GMT -5
Stealth. According to Griffin, toujeo's appeal to Sanofi (aka Snafu-i) may fade as early as Jan. 16. Those folks at Griffin seem to have good insights. Or, maybe I just agree with them. You found the operative word. STEALTH. We can argue if the application is for Afrezza or not, but its undeniable there exist an EU application for human insulin. Either way its being done by someone and with stealth. Whoever submitted it has had a tough time of it. Over a year in submission, and with unanswered "120 day" questions (similar to a CRL, but not as calamitous as the applications stays open), requested an extension to answer those questions. |
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Post by compound26 on Nov 17, 2015 16:05:37 GMT -5
FWIT, for your information: 1. It appears this mysterious "human insulin" first appeared in EMA's "Medicines under evaluation" list in July 2014. So it appears the application was first submitted and accepted by EMA in or around July 2014. 2. When it was on the list, Insulin glargine (apparently, Toujeo) was also grouped in the same list as " Non-orphan generic and biosimilar medicinal products", the same as this mysterious "human insulin". 3. In November 2012, there was also a "human insulin" applications (actually noted as 3 applications in total) in the same list as "Non-orphan generic and biosimilar medicinal products", but it then disappeared in the subsequent lists (though I did not verify each list to confirm this) and apparently until the same name reappeared in the July 2014 list. 4. It appears Insulin glargine (apparently, Toujeo) first appeared in EMA's "Medicines under evaluation" list in July 2013. So it appears the application was first submitted and accepted by EMA in or around July 2013. Considering that Toujeo obtained CHMP opinion in Feb 2015 and official EMA approval in April 2015, the whole process took about two years for Toujeo. So whatever this mysterious "human insulin" turns out to be, if it gets CHMP opinion this month and official EMA approval in Jan. 2016, that's not too shabby. The above information is from EMA's website at: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/document_listing/document_listing_000349.jsp&mid=WC0b01ac05805083eb#section1 |
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Post by lakers on Nov 17, 2015 16:15:56 GMT -5
If this does turn out to be Afrezza related, it explains a number of critical questions that are circulating, not the list of which is why the safety study has yet to initiate. Of course, the EMA's opinions on study design would be an absolute requirement before initiating that expense. That the FDA required this safety study is itself yet another reason why the EMA approval process absolutely should have been initiated at the earliest opportunity, so as to be able to achieve that input at the right time. Combined study design requirements to be agreed upon by 4/30/2016. One stone kills three birds. Finally someone figured it out! |
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Post by peppy on Nov 17, 2015 16:27:45 GMT -5
If this does turn out to be Afrezza related, it explains a number of critical questions that are circulating, not the list of which is why the safety study has yet to initiate. Of course, the EMA's opinions on study design would be an absolute requirement before initiating that expense. That the FDA required this safety study is itself yet another reason why the EMA approval process absolutely should have been initiated at the earliest opportunity, so as to be able to achieve that input at the right time. Combined study design requirements to be agreed upon by 4/30/2016. One stone kills three birds. Finally someone figured it out! You people that completely understand what lakers is saying, please tell me in the "dumbed down" version. Thanks
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Post by jeremg on Nov 17, 2015 16:37:14 GMT -5
Combined study design requirements to be agreed upon by 4/30/2016. One stone kills three birds. Finally someone figured it out! You people that completely understand what lakers is saying, please tell me in the "dumbed down" version. Thanks
I believe Lakers is referring to EMA approval of Afrezza showing SNY's commitment, showing EMA approval (obciously), as well as removing the roadblock for the post approval safety study which would allow it to commense under EMA guidelines as well as FDA. |
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Post by derek2 on Nov 17, 2015 17:39:20 GMT -5
You people that completely understand what lakers is saying, please tell me in the "dumbed down" version. Thanks
I believe Lakers is referring to EMA approval of Afrezza showing SNY's commitment, showing EMA approval (obciously), as well as removing the roadblock for the post approval safety study which would allow it to commense under EMA guidelines as well as FDA. The difficulty being, of course, that MNKD has stated that EU approval has not yet been applied for, SNY does not list Afrezza as one of the drugs they have international applications pending approval, and the application in question from an unnamed sponsor is over a year old, pre-dating the Mannkind / SNY partnership. It truly strains credulity. |
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Post by james on Nov 17, 2015 17:56:46 GMT -5
To me, this would also tie in with:
1) Subzone status application
2) Management's apparent attitudes on liquidity (they would know what questions and issues are at stake throughout the application process and have some sense of the probability for success)
and quite possibly:
3) Why the negative press is at a fever pitch
far less certain, but also possibly:
4) Timing of SNY insulin qualification to ex-US launches and the scale of the Amphastar commitment (knowing SNY would want to provide supply)
Ok - so, to step back for a moment. I have no better idea than anyone else if this has been going on under our noses. It is equally likely to be a complete fantasy, but the pieces line up very well. Is management trying to shoot the moon?
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Post by james on Nov 17, 2015 18:04:33 GMT -5
I believe Lakers is referring to EMA approval of Afrezza showing SNY's commitment, showing EMA approval (obciously), as well as removing the roadblock for the post approval safety study which would allow it to commense under EMA guidelines as well as FDA. The difficulty being, of course, that MNKD has stated that EU approval has not yet been applied for, SNY does not list Afrezza as one of the drugs they have international applications pending approval, and the application in question from an unnamed sponsor is over a year old, pre-dating the Mannkind / SNY partnership. It truly strains credulity. They would not be able to simultaneously keep the sponsor anonymous on the application and state that approval has been applied for. Why keep it so anonymous? There is a definite desire to keep information out of the public sphere in regards to the details of the partnership. I guess I don't entirely understand the depth of that secrecy either. On the other hand, it might have been judged as a high risk application and neither party wanted to impede the U.S. launch by disclosing that another agency was reviewing the drug. That could have certainly delayed adoption as folks waited for a second opinion. |
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Post by jpg on Nov 17, 2015 18:15:40 GMT -5
Who ever is doing this wants it to be kept secret. Would a company introducing a biosimilar want as much secrecy as possible? Certainly. Is this for Afrezza or a biosimilar? We will soon find out but i have a feeling we will again be disappointed...
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Post by jeremg on Nov 17, 2015 18:18:09 GMT -5
I believe Lakers is referring to EMA approval of Afrezza showing SNY's commitment, showing EMA approval (obciously), as well as removing the roadblock for the post approval safety study which would allow it to commense under EMA guidelines as well as FDA. The difficulty being, of course, that MNKD has stated that EU approval has not yet been applied for, SNY does not list Afrezza as one of the drugs they have international applications pending approval, and the application in question from an unnamed sponsor is over a year old, pre-dating the Mannkind / SNY partnership. It truly strains credulity. Well that's where the whole "applied secrecy" theory comes into play pick your side, someone will be proven right soon. |
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Post by james on Nov 17, 2015 18:46:03 GMT -5
The difficulty being, of course, that MNKD has stated that EU approval has not yet been applied for, SNY does not list Afrezza as one of the drugs they have international applications pending approval, and the application in question from an unnamed sponsor is over a year old, pre-dating the Mannkind / SNY partnership. It truly strains credulity. The application apparently could have been filed as late as September 2014 and made it to the October 2014 CHMP meeting. October is the fist public record of EMEA/H/C/003858. So, I don't think there is specific evidence that the application was filed prior to the partnership agreement which was signed Aug. 11, 2014. Nevertheless, there would likely have been some initial collaboration prior to formalizing the partnership to get this off the ground that quickly. |
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Post by slugworth008 on Nov 17, 2015 19:13:13 GMT -5
At the end of the day - How hard is it for SNY to simply state that they've filed for E.U. approval for Afrezza. All this cloak and dagger BS for a product already known to ALL
other B.P.'s is Ricola Ridiculous. SNY should grow a pair get it out there. Let it be known they are coming after marketshare. IMO we are waaay past secrecy at this point.
Just my take.
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Post by mindovermatter on Nov 17, 2015 19:48:26 GMT -5
Maybe I missed it but why would Sanofi want to keep EU launch a secret? It didn't keep US launch a secret. What exactly would they gain by "surprising" anyone and everyone by doing so?
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