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Post by compound26 on Nov 19, 2015 17:29:02 GMT -5
If there is any remote chance that the "insulin human" being reviewed by EMA is Afrezza, they are supposed to have a "CHMP opinion" today and we will probably know the result by tomorrow. If it is not Afrezza, we will also know. I thought the decision was due on Nov. 25th? Are we actually going to privy to the decision tomorrow?! I do not know where people get this 25 November 2015 date. I understand CHMP generally releases its opinion the day after the meeting. For example, for Toujeo, the CHMP meeting was from 23 to 26 of Feb., 2015. CHMP opinion was dated 26 February 2015. CHMP released the opinion on 27 Feb. 2015. And on 27 February 2015, Sanofi announced the result. Somehow the link below does not work, but here what Sanofi announced on 27 Feb. 2015: February 27, 2015 Paris, France - February 27, 2015 - Sanofi announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL), a next-generation basal insulin for the treatment of adults with type 1 and type 2 diabetes. Toujeo has demonstrated a more stable and a prolonged glycemic control that lasts beyond 24 hours compared with Lantus® (insulin glargine [rDNA origin] injection, 100 U/mL) with low within-individual, within-day blood sugar variability.1-3 " Today's CHMP opinion is another step forward to make Toujeo available to people living with diabetes who are currently not at their glycemic target, or are about to start insulin therapy," said Pierre Chancel, Senior Vice President, Global Diabetes, Sanofi. "We are confident that we can soon add this new treatment option to our portfolio to help patients reach their blood sugar goals." The CHMP positive opinion of Toujeo is based on results from the EDITION clinical trial program, a worldwide and extensive series of Phase III studies evaluating the efficacy and safety of Toujeo compared to Lantus in more than 3,500 adults with type 1 or type 2 diabetes who were uncontrolled on their current therapy.4-9 Toujeo demonstrated effective blood sugar control, with a favorable safety profile. Toujeo significantly lowered hypoglycemic (low blood sugar) risk in people with type 2 diabetes both at any time of the day and night-time compared with Lantus.10 The European Commission (EC) is expected to make a final decision on granting marketing authorization for Toujeo in the EU in the coming months. Toujeo was approved by the U.S. Food and Drug Administration and is under review by other regulatory authorities around the world. Once approved, Toujeo will be available in the Toujeo SoloSTAR®, a disposable prefilled pen which contains 450 insulin units (IU), and it has a maximum single injection dose of 80 IU. en.sanofi.com/NasdaQ_OMX/local/press_releases/toujeo_receives_positive_opini_1897975_27-02-2015!13_15_43.aspx
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Post by dreamboatcruise on Nov 19, 2015 17:35:00 GMT -5
If there is any remote chance that the "insulin human" being reviewed by EMA is Afrezza, they are supposed to have a "CHMP opinion" today and we will probably know the result by tomorrow. If it is not Afrezza, we will also know. So remote as to be indistinguishable from non existent If they announce it is approved or rejected, how does that prove/disprove whether it has anything to do with Afrezza?
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Post by Deleted on Nov 19, 2015 17:37:02 GMT -5
Here's what doesn't pass the sniff test: you don't use the ATM now if you're going to announce a TS partnership in the next month/quarter unless a) the partnership isn't a very good deal or b) you're blowing smoke.
I find it difficult to believe you even use the ATM if you're expecting to go into the clinic in the next few months, because once API and clinic data is released you'd expect a valuation bump.
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Post by compound26 on Nov 19, 2015 17:37:46 GMT -5
If there is any remote chance that the "insulin human" being reviewed by EMA is Afrezza, they are supposed to have a "CHMP opinion" today and we will probably know the result by tomorrow. If it is not Afrezza, we will also know. So remote as to be indistinguishable from non existent If they announce it is approved or rejected, how does that prove/disprove whether it has anything to do with Afrezza? I think in the CHMP opinion, they will refer to the actual drug rather than "insulin human" and probably also the applicant for the drug. So we will know what that is about.
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Post by suebeeee1 on Nov 19, 2015 17:39:56 GMT -5
What could possibly be the reason that Sny would delay submitting Afrezza to the EMA when it fast tracked Toujeo which received EMA approval before FDza approval.?. This has got to be it.
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Post by jeremg on Nov 19, 2015 17:41:59 GMT -5
compound26 I had seen someone reference the 25th as the date for a decision, I looked back but can't remember who or where I had seen this. The meeting goes through the 22nd so I wouldn't expect information before then, I'm not familiar with how this information from the meeting becomes public either but do we even know whether they would reveal this drug is Afrezza in the case it was approved? Best case scenario we may be waiting for validation from the black-hole duo in the coming weeks. All I want for Christmas is an end to this need for speculation, let's get some material information, I'm talking to you SNY & MNKD!
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Post by compound26 on Nov 19, 2015 17:54:20 GMT -5
compound26 I had seen someone reference the 25th as the date for a decision, I looked back but can't remember who or where I had seen this. The meeting goes through the 22nd so I wouldn't expect information before then, I'm not familiar with how this information from the meeting becomes public either but do we even know whether they would reveal this drug is Afrezza in the case it was approved? Best case scenario we may be waiting for validation from the black-hole duo in the coming weeks. All I want for Christmas is an end to this need for speculation, let's get some material information, I'm talking to you SNY & MNKD! The meeting is from 16-19, November 2015. 16/11/2015 - 19/11/2015 : CHMP Committee for Medicinal Products for Human Use (CHMP): 16-19 November 2015 The Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning human medicines. www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/landing/chmp_meetings_landing_page.jsp&mid=WC0b01ac0580028c7d
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Post by jeremg on Nov 19, 2015 17:59:41 GMT -5
compound26 I had seen someone reference the 25th as the date for a decision, I looked back but can't remember who or where I had seen this. The meeting goes through the 22nd so I wouldn't expect information before then, I'm not familiar with how this information from the meeting becomes public either but do we even know whether they would reveal this drug is Afrezza in the case it was approved? Best case scenario we may be waiting for validation from the black-hole duo in the coming weeks. All I want for Christmas is an end to this need for speculation, let's get some material information, I'm talking to you SNY & MNKD! The meeting is from 16-19, November 2015. 16/11/2015 - 19/11/2015 : CHMP Committee for Medicinal Products for Human Use (CHMP): 16-19 November 2015 The Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning human medicines. www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/landing/chmp_meetings_landing_page.jsp&mid=WC0b01ac0580028c7dOkkkkk, I was using the information from the original thread which was actually just a review of the agenda back in October (Oct. 19-22). I thought that to be the only source of information we had. Good find, why didn't I think of simply looking on the EMA website... www.ema.europa.eu/docs/en_GB/document_library/Agenda/2015/10/WC500195779.pdf
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Post by EveningOfTheDay on Nov 19, 2015 18:05:37 GMT -5
Here's what doesn't pass the sniff test: you don't use the ATM now if you're going to announce a TS partnership in the next month/quarter unless a) the partnership isn't a very good deal or b) you're blowing smoke. I find it difficult to believe you even use the ATM if you're expecting to go into the clinic in the next few months, because once API and clinic data is released you'd expect a valuation bump. Exactly. I did not wanted to be the bubble burster, but little of what is going on makes sense. It is very possible that for the time being this is as good as it gets. I wish I would see hope to think differently and I absolutely wish MNKD will prove me wrong, but I am fairly disenchanted with management at this point. Too bad because obviously Afrezza works better than anything else out there.
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Post by james on Nov 19, 2015 18:13:19 GMT -5
I would not expect that a TS partnership at the current development stage would be all that likely to yield a large amount of upfront cash. I'd be surprised if it could bring $100M say without giving away nearly all the future royalty stream. What it certainly could do is offload a good chunk of ongoing development expense and that would be a definite help.
I don't know what is up with the liquidity situation. I certainly expect that there is more of a plan in place than the pundits are giving credit for. Whether it is any good or not, I don't know.
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Post by peppy on Nov 19, 2015 18:45:03 GMT -5
So remote as to be indistinguishable from non existent If they announce it is approved or rejected, how does that prove/disprove whether it has anything to do with Afrezza? I think in the CHMP opinion, they will refer to the actual drug rather than "insulin human" and probably also the applicant for the drug. So we will know what that is about. Compound and all, Will you post the opinion when it comes out? Do you have a link for the opinion? Europe so they are 6 hours earlier than EST.
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Post by compound26 on Nov 19, 2015 18:52:09 GMT -5
I think in the CHMP opinion, they will refer to the actual drug rather than "insulin human" and probably also the applicant for the drug. So we will know what that is about. Compound and all, Will you post the opinion when it comes out? Do you have a link for the opinion? Europe so they are 6 hours earlier than EST.
You can follow EMA_News if you want update from them:
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Post by dreamboatcruise on Nov 19, 2015 19:37:40 GMT -5
What could possibly be the reason that Sny would delay submitting Afrezza to the EMA when it fast tracked Toujeo which received EMA approval before FDza approval.?. This has got to be it. If they knew that the label they got in the U.S. would mean national health systems in EU wouldn't cover Afrezza if the same label were applied there, so they delayed to do what is necessary to get a better label in EU from the start?
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Post by kball on Nov 19, 2015 19:58:38 GMT -5
Compound working overtime...nice job of late btw
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Post by bill on Nov 19, 2015 20:36:28 GMT -5
On what could be a related note, The MNKD short volume ratio hit an all-time low of 7.5% today. Coincidence that Lakers said BOD were meeting today? Perhaps tomorrow will add more clarity in some way.
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