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Post by jeremg on Nov 16, 2015 23:39:02 GMT -5
"Initial applications (section 3)
This section lists applications for marketing authorisations of new medicines that are to be discussed by the Committee.
Section 3.1 is for medicinal products nearing the end of the evaluation and for which the CHMP is expected to adopt an OPINION at this meeting on whether marketing authorisation should be granted. Once adopted, the CHMP opinion will be forwarded to the European Commission for a final legally binding decision valid throughout the EU."
INSULIN HUMAN - SCOPE: OPINION - ACTION: ADOPTION
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Post by gwb on Nov 17, 2015 0:39:55 GMT -5
You are exactly right! I just answered my own question by reading through the last few pages of the EMA information. This is the "Opinion" step for "Adoption" which means they will give a verdict on whether to adopt the drug or not during this meeting. So the good news is we will know in short order. The bad news, I just somehow don't think this is Afrezza based on the "Insulin Human" tag alone and the fact this is already judgment day for this drug. I would expect Technosphere itself would need to be reviewed with some "FDKP" tag as opposed to just "Insulin Human" and SNY surely didn't start this process 210 days ago while keeping things hush hush up until EMA approval as MNKD burns. As the adoption drugs have names , it possibility could be Afrezza which is listed as only human insulin . The first link below says it's up to the company during the evaluation and the second link on slide 10 of 21 says the secondary evaluation ends at day 210 .
mnkd.proboards.com/thread/3326/afrezza-approval-Europe
3. During the evaluation process, the EMA is very transparent to the companies that apply for drug approval. It is up to the company, during the evaluation, on how transparent it wants to be with the public. In my experience the EMA announces new MAA's on its website shortly after they are received. When the EMA makes a decision it will be made public and its rationale for approving or rejecting the MAA will be available to the public.
Slide 10 of 21 on the next link shows the evaluation period to end at 210 days ( Secondary Evaluation ) www.ema.europa.eu/docs/en_GB/document_library/Presentation/2009/10/WC500004235.pdf
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Post by liane on Nov 17, 2015 5:09:32 GMT -5
I merged the 2 threads started by lakers.
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Post by Deleted on Nov 17, 2015 7:33:25 GMT -5
I emailed Matt regarding this matter, if he replies I will post his response.
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Post by rockstarrick on Nov 17, 2015 10:05:08 GMT -5
You are exactly right! I just answered my own question by reading through the last few pages of the EMA information. This is the "Opinion" step for "Adoption" which means they will give a verdict on whether to adopt the drug or not during this meeting. So the good news is we will know in short order. The bad news, I just somehow don't think this is Afrezza based on the "Insulin Human" tag alone and the fact this is already judgment day for this drug. I would expect Technosphere itself would need to be reviewed with some "FDKP" tag as opposed to just "Insulin Human" and SNY surely didn't start this process 210 days ago while keeping things hush hush up until EMA approval as MNKD burns. The tag "Insulin Human", and the length of time our Afrezza "Insulin Human" has been on this, since September 2014, suggests to me that some type of Technosphere review or "Special" safety trial, (like the live trial now ongoing in the United States) could very well be the hold up. In 2014, both Toujeo and Afrezza were on the list, (Afrezza directly under Toujeo), and both listed by Sanofi, while Toujeo was quickly approved, Afrezza is still pending, (or not even submitted ??), why. Why did Toujeo and Afrezza wind up on the same list in 2014, listed by Sanofi, (in 2014), and Toujeo moves on through the approval process to gain approval status, and Afrezza does nothing ?? Can anybody actually find another insulin product with the tag "insulin Human" after the registered name ?? If you go to Afrezza.com you will see this tag, "Insulin Human" immediately after Afrezza, then directly below this you will see, "Insulin Human Inhalation Powder". I haven't been able to find another insulin product with the tag "Insulin Human" in that order. I guess we wait for November 25, but while we wait, can anybody find another insulin product with the tag "Insulin Human" in that order, and can anyone answer the question on how Toujeo and Afrezza ended up on the same list in 2014, listed by Sanofi. Has anybody from Mannkind ever stated that Sanofi has NOT submitted for approval in other countries, or have they made open ended statements, leaving the topic open for speculation. I don't know the answer, anybody else ?? Good Luck Longs. |
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Post by compound26 on Nov 17, 2015 10:28:59 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.
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Post by Deleted on Nov 17, 2015 10:35:29 GMT -5
2. Mannkind and Sanofi has the incentive to keep the application underradar. So no reference to Afrezza or technoshere is understandable, if it is permitted.
Why? |
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Post by compound26 on Nov 17, 2015 10:41:29 GMT -5
2. Mannkind and Sanofi has the incentive to keep the application underradar. So no reference to Afrezza or technoshere is understandable, if it is permitted.
Why? 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. |
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Post by mssciguy on Nov 17, 2015 10:54:42 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.  |
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Post by jpg on Nov 17, 2015 11:05:15 GMT -5
You do make a good case for EU application. That certainly would be a very positive development but as usual with Mannkind we are basing stuff on second degrees of evidence. The secrecy is impressive.
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Post by mssciguy on Nov 17, 2015 11:13:02 GMT -5
You do make a good case for EU application. That certainly would be a very positive development but as usual with Mannkind we are basing stuff on second degrees of evidence. The secrecy is impressive. sorry to go off topic, but you are right about the impressive secrecy. Even our govt can't do it that well. I can share with you that a little bird told me that SEC is aware of the manipulation, however. Don't know if anything will come of it anytime soon. It would be a good idea to keep records of losses (I know some options holders have been burned, for example), also contacts with SEC. |
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Post by lakers on Nov 17, 2015 11:15:41 GMT -5
Toujeo is just a transitional step. Sny fast tracks Lixilan which has GLP-1. IMHO, jpg knew this. They plan to market/push Lixilan+Afrezza together. The Lethal combo will shake up and reinvigorate their diabetes biz.
Per agreement, $30M (not $35M) for EU Approval, $20M for Japan Approval. You can easily verify this.
Sny and MNKD are really stealthy.
Olivier reset the bar very low. Under-promise, over-deliver. Classic Wall St mgmt.
They will strike with Shock and Awe. What a Muhammad Ali's Rope and Dope.
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Post by mnkdorbust on Nov 17, 2015 11:21:11 GMT -5
I wish they would fast track taking a stock ownership in MNKD.
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Post by rockstarrick on Nov 17, 2015 11:25:08 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 July 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 $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 speculations. Just for your entertainment. I would give it a 50% chance that this is Afrezza-related.
Great summary and imagination !! Just have 2 comments, Afrezza was FDA approved on June 27 2014, and added to the list in September 2014, by Sanofi, not Mannkind. I also believe there is at least a 50/50 chance this is Afrezza. |
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Post by mnholdem on Nov 17, 2015 11:29:56 GMT -5
Sanofi did not become the Afrezza distributor until August 11, 2014. The earliest statements by management about MannKind's partnership with Sanofi mentions getting Afrezza into international markets ASAP, which is where all this speculation is coming from. Why would Al Mann say that if Sanofi was going to wait more than a year?
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I would give it a 50% chance that this is Afrezza-related. 
