|
|
Post by james on Nov 17, 2015 19:55:01 GMT -5
It's not an EU launch that would be kept secret here, it is the status of an application for approval by a regulatory body. The secrecy would possibly be to avoid distraction from the current U.S. launch or other negotiations. It could also be for competitive reasons.
It's all complete speculation of course.
|
|
|
|
Post by derek2 on Nov 17, 2015 20:32:54 GMT -5
In May, 2015, Hakan flat-out stated that SNY and MNKD had yet to finalize a date for EU application. The anonymous application that there's discussion of in this thread was already filed before that. It's really that simple.
Then in June 2015 at the GS Global Healthcare Conference:
During the Q2 earnings call, in August, Matt said:
|
|
|
|
Post by rockstarrick on Nov 17, 2015 21:31:47 GMT -5
In May, 2015, Hakan flat-out stated that SNY and MNKD had yet to finalize a date for EU application. The anonymous application that there's discussion of in this thread was already filed before that. It's really that simple. Then in June 2015 at the GS Global Healthcare Conference: During the Q2 earnings call, in August, Matt said: Appreciate you sharing the quotes from the conference calls, but like I said earlier in this thread, they have not said Sanofi hasn't filed. In my opinion, these are open ended statements that leave this topic open for speculation "I can't give you specifics at this point" It seems that they would just come out and say, the submission for insulin human is NOT Afrezza, but they don't. So we continue to speculate until November 25th. Good Luck To You |
|
|
|
Post by jpg on Nov 17, 2015 21:51:36 GMT -5
What a frustrating company to be interested in!
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Nov 17, 2015 21:53:40 GMT -5
In May, 2015, Hakan flat-out stated that SNY and MNKD had yet to finalize a date for EU application. The anonymous application that there's discussion of in this thread was already filed before that. It's really that simple. Then in June 2015 at the GS Global Healthcare Conference: During the Q2 earnings call, in August, Matt said: Appreciate you sharing the quotes from the conference calls, but like I said earlier in this thread, they have not said Sanofi hasn't filed. In my opinion, these are open ended statements that leave this topic open for speculation "I can't give you specifics at this point" It seems that they would just come out and say, the submission for insulin human is NOT Afrezza, but they don't. So we continue to speculate until November 25th. Good Luck To You Hakan Edstrom - Chief Executive Officer It’s very active way of discussion. People asked about Europe a lot. I mean, we did design our Phase 3 studies with European mind and based on discussions we have with them. So there is some hope that we could file there fairly quickly. That said, I mean, we asked them years ago about that and we all know things change in the regulatory agencies, so about to be approached and talk to. And I think there are these discussions like that going on to see what if anything might still be required to file in those kinds of jurisdictions. Read more: mnkd.proboards.com/thread/3776/evidence-maa-chmp-oct-agenda?page=7#ixzz3ro93dip9 |
|
|
|
Post by trenddiver on Nov 17, 2015 22:36:16 GMT -5
What a frustrating company to be interested in! jpg Why are you frustrated? I thought I remember you posting recently that you sold your entire positions. Tren |
|
|
|
Post by mnkdorbust on Nov 17, 2015 22:51:55 GMT -5
Based on past experiences maybe it is being kept secret so intervention like that that initially delayed Afrezza being approved by the FDA doesn't happen with other agencies. There is so much manipulation and secrecy going on so who knows anymore. I'm hoping it's for Afrezza but expecting to find out it's not. Going in with low expectations = less of a let down.
|
|
|
|
Post by jay1ajay1a on Nov 18, 2015 0:20:53 GMT -5
I think there have been discussions on whether this is related to Afrezza. Argument against that this is Afrezza has been made (i.e., no name, biosimilar, etc.). I am not going to repeat them. I think there are also a few arguments for that this is related to Afrezza. 1. the timeline seems to match. It appears this application first generated a CHMP list of questions in October 2014. So this application was probably submitted anywhere between June 2014 to Sept. 2014. Given that Afrezza received affirmative Adcom vote in April 2014 and FDA approval in June 2014, it is not inconceivable that Mannkind had most of the documents ready to submit for EMA approval in the summer of 2014. Note that in this interview done in Sept. 2014, Al Mann said "The plan is to launch Afrezza in the first quarter of 2015. We will spend the next few months preparing for that launch. Sanofi had already done a great deal of work preparing for the launch — they started even before we had signed the agreement. They have set up an extensive team for the commercialization and that team is hard at work in planning the launch." It won't surprise among the work done by Sanofi before the signing of the partnership, there was coordination between the parties on EMA approval. Given the above, it won't surprise me that Mannkind prepared and submitted the EMA application in June/July 2014 and Sanofi took it over (or most part of it if the application was still in the name of Mannkind) after the partnership was signed, or alternatively, Sanofi had already discussed the EMA application with Mannkind before the partnership agreement was formally signed and then submitted the application right after the partnership agreement was signed. Also, since both Sanofi and Mannkind knew that the EMA approval was a lengthy process, there was no reason for them to wait. Rather, they probably wanted to submit an application as early as possible. Note that Toujeo received FDA approval on Feb. 25, 2015 and got the EMA CHMP opinion on Feb. 26, 2015 and EMA approval two months later. So for Toujeo, the FDA and EMA applications were carried out around the same timeline. 2. Mannkind and Sanofi have the incentive to keep the application underradar. So no reference to Afrezza or technoshere is understandable, if it is permitted.
3. the fact that the applicant actually extended the deadline to respond to the questions suggest that this is a major (and complex) application (not like a simple biosimilar product).
4. the fact that Sanofi has the clamp study done in Germany, instead of in US or some other developing countries (cheaper) suggests that the clamp study data may be used for the EMA application and approval.
5. the fact that Sanofi completed the study ahead of schedule (I understand that it was originally supposed to complete in December 2015) in September 2015 suggests that Sanofi needs the data for use at sometime after September. This seems to match the October oral presentation date set by the CHMP.
6. EMA formal approval is generally given two months after CHMP opinion.
If this is related to Afrezza, then Afrezza will get formal EMA approval in Jan. 2016. If that is the case, this seems to explain why Matt used the cash to paid off the debt as he probably was pretty certain that he would get $30/35 million milestone payment for EMA approval in another quarter. (If there is EMA approval, then perhaps also the rumored $25 million milestone payment for the Sanofi insulin certification).
7. If there is going to be EMA approval and global expansion, this also seems to explain the subzone application recently done by Mannkind.
8. This also seems to explain why the JV's expenses have been pretty high. If we just for argument's sake, take out $10 million of expenses per quarter for EMA application activities (there probably is team working on the application and approval), then the expenses will look much reasonable.
Anyway, the above are just my wild speculations. Just for your entertainment.  I would give it a 50% chance that this is Afrezza-related.
I have been away for a bit and just now reviewed this. I think your logic is reasonable and many of of your comments seems possible. I cant wait till then, we need a break!!!! |
|
|
|
Post by rrtzmd on Nov 18, 2015 0:21:45 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#section1There is really nothing mysterious that I can see. The October meeting lists one application for insulin under "Non-orphan generic and biosimilar medicinal products." Obviously, afrezza is not a generic. If you look at how the agency defines "biosimilar": defining biosimilar...and look under "Application of the biosimilar approach" on pages 4 and 5, it should be obvious that afrezza does not qualify. Although several of the details would likely disallow it, perhaps the most relevant is probably this one: "The posology and route of administration of the biosimilar must be the same as those of the reference medicinal product." While "route of administration" could make afrezza similar to exubera, posology -- referring to dosing -- is completely different than any other product -- at least I can think of no other drug that doses by blue and green cartridges. Hence, whatever insulin is being referred to as having an application under "generic and biosimilar" extremely unlikely to be afrezza. |
|
|
|
Post by jpg on Nov 18, 2015 0:31:51 GMT -5
What a frustrating company to be interested in! jpg Why are you frustrated? I thought I remember you posting recently that you sold your entire positions. Tren Yes I sold. Why is that pertinent as to me thinking Mannkind is a frustrating company to try and figure out? Investing is not not necessarily being invested but being interested. I've been following some biotechs for years and never bought (Celgene being the one that I still follow but haven't bought yet). When I stop following a company it's because I think they are not worth it or not investible. Mannkind isn't there yet for me but they did fall of my investment risk reward for the first time in 8 years. And it's not the price. Would it make it easier for your paradigms if I bought 100 shares and now called myself an investor? I used to do that but now i can comfortably site on the sidelines and follow a company without any financial stake. It sometimes makes for far better objective evaluation! |
|
|
|
Post by jay1ajay1a on Nov 18, 2015 0:32:30 GMT -5
Agree Peppy, If Afrezza has to be submitted by name, why would the EMA allow any human insulin drug to be listed as "Insulin Human" no name listed ?? Because "human insulin" is just that -- human insulin. Humulin R, for example, is just human insulin -- recombinant, yes, but still just plain human insulin. Any generics of humulin R therefore qualify as being called "human insulin." Afrezza is a separate drug -- a combination of human insulin with FDKP particles. As such it has its own specific name and that is the name it must use to apply for approval. I like! |
|
|
|
Post by jay1ajay1a on Nov 18, 2015 0:38:24 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!We hope, seem very possible. |
|
|
|
Post by gamblerjag on Nov 18, 2015 0:44:27 GMT -5
Curious...sorry.... off topic.. couldn't start a new thread.. Administrators .. thanks for all you do here.. Is there any way we can get the page numbers on the bottom of the page too.. would make it easier then to scroll all the way back to the top to go to the next page.. Thanks if you can.
|
|
|
|
Post by rockstarrick on Nov 18, 2015 2:25:41 GMT -5
Appreciate you sharing the quotes from the conference calls, but like I said earlier in this thread, they have not said Sanofi hasn't filed. In my opinion, these are open ended statements that leave this topic open for speculation "I can't give you specifics at this point" It seems that they would just come out and say, the submission for insulin human is NOT Afrezza, but they don't. So we continue to speculate until November 25th. Good Luck To You Hakan Edstrom - Chief Executive Officer It’s very active way of discussion. People asked about Europe a lot. I mean, we did design our Phase 3 studies with European mind and based on discussions we have with them. So there is some hope that we could file there fairly quickly. That said, I mean, we asked them years ago about that and we all know things change in the regulatory agencies, so about to be approached and talk to. And I think there are these discussions like that going on to see what if anything might still be required to file in those kinds of jurisdictions. Read more: mnkd.proboards.com/thread/3776/evidence-maa-chmp-oct-agenda?page=7#ixzz3ro93dip9Yes, I saw this quote earlier. I am fairly confident MNKD management is aware of this "insulin Human" submission and the speculation it has caused. In my opinion, it would be very easy for Matt or Hakan to just come out and say, the EMA submission for "Insulin Human" is definetly NOT Afrezza. This would end all speculation, but they don't. The results of the EMA discussion on this "Insulin Human" will be released November 25th. We don't have long to wait. Good Luck to you. |
|
|
|
Post by liane on Nov 18, 2015 5:07:47 GMT -5
Curious...sorry.... off topic.. couldn't start a new thread.. Administrators .. thanks for all you do here.. Is there any way we can get the page numbers on the bottom of the page too.. would make it easier then to scroll all the way back to the top to go to the next page.. Thanks if you can. The page number location is not something we can alter. Yes, it would be nice to also have them at the bottom of the page. All I can say is that the numbers are visible all the way down to the reply box, but if you scroll to the very bottom of the page, they do disappear. |
|
I would give it a 50% chance that this is Afrezza-related. 
