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Post by saxcmann on Nov 17, 2015 11:36:55 GMT -5
Great post above Compound26! Makes sense! Mnkd has enough money to get them through January. Probably why January options so high as well? Maybe buy-in our buyout just before EMA approval? Just speculating...
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Post by suebeeee1 on Nov 17, 2015 11:49:06 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. Makes me want to don my tin hat as well....Conspiracies abound! |
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Post by rockstarrick on Nov 17, 2015 11:54:42 GMT -5
any truth to this?
the agenda for the CHMP evaluation meeting 19-22 Oct is out
.
Pre authorisation process : Insulin Human (003858) : oral explanation given tomorrow 10/20
I tried going through search and got lost looking at the link. I saw insulin, technosphere I did not see.
2.1.1. - insulin human - EMEA/H/C/003858
treatment of diabetes
Scope: Oral explanation
Action: Oral explanation to be held on Tuesday 20 October 2015 at 9.00.
List of Outstanding Issues adopted on 25.06.2015. List of Questions adopted on 23.10.2014.
My attempt to keep this thread on topic. |
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Post by bradleysbest on Nov 17, 2015 11:59:00 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. I would prefer a GGG style beat down of the shorts with a finishing left hook to the body! Momma said knock you out! |
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Post by peppy on Nov 17, 2015 12:13:00 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. I would prefer a GGG style beat down of the shorts with a finishing left hook to the body! Momma said knock you out! They plan to market/push Lixilan+Afrezza together. That makes sense. screencast.com/t/lfvJnQwPlF5H
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Post by rrtzmd on Nov 17, 2015 12:21:26 GMT -5
any truth to this?
the agenda for the CHMP evaluation meeting 19-22 Oct is out
.
Pre authorisation process : Insulin Human (003858) : oral explanation given tomorrow 10/20
I tried going through search and got lost looking at the link. I saw insulin, technosphere I did not see.
2.1.1. - insulin human - EMEA/H/C/003858
treatment of diabetes
Scope: Oral explanation
Action: Oral explanation to be held on Tuesday 20 October 2015 at 9.00.
List of Outstanding Issues adopted on 25.06.2015. List of Questions adopted on 23.10.2014.
My attempt to keep this thread on topic. It does not have anything to do with afrezza. Afrezza is not human insulin! It is afrezza -- human insulin encapsulated in FDKP particles. When its application is filed, it will have to be for the drug, afrezza. |
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Post by peppy on Nov 17, 2015 12:30:33 GMT -5
From the post directly above; It does not have anything to do with afrezza. Afrezza is not human insulin! It is afrezza -- human insulin encapsulated in FDKP particles. When its application is filed, it will have to be for the drug, afrezza.
Fourth post in this thread;
Some people think this application is for Afrezza and that Sanofi has been granted anonymity by the EMA. If so, the decision to authorize will be made within 45 days, if no issues remain unresolved. There are many people who think that this EMA case is NOT related to Afrezza (such as the use of "biosimilar" in describing the drug) but I think we should be able to put the debate to bed soon.
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Post by rockstarrick on Nov 17, 2015 12:43:07 GMT -5
From the post directly above; It does not have anything to do with afrezza. Afrezza is not human insulin! It is afrezza -- human insulin encapsulated in FDKP particles. When its application is filed, it will have to be for the drug, afrezza. Fourth post in this thread; Some people think this application is for Afrezza and that Sanofi has been granted anonymity by the EMA. If so, the decision to authorize will be made within 45 days, if no issues remain unresolved. There are many people who think that this EMA case is NOT related to Afrezza (such as the use of "biosimilar" in describing the drug) but I think we should be able to put the debate to bed soon. 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 ?? |
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Post by gamblerjag on Nov 17, 2015 12:53:34 GMT -5
Did we ever learn what Matt whispered to Al earlier this year at the meeting they had. I don't know if that was the same meeting that Al talked about his wifes migranes. But Al spoke out of turn and Matt quickly told him we haven't divulged that or we haven't disclosed that yet. Anyone remember?
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Post by mnkdnut on Nov 17, 2015 13:02:06 GMT -5
I would prefer a GGG style beat down of the shorts with a finishing left hook to the body! Momma said knock you out! They plan to market/push Lixilan+Afrezza together. That makes sense. screencast.com/t/lfvJnQwPlF5H
The disappointing impression I got from the SNY CC was that Lixilan alone would be the first line treatment, based on the assumption that the GLP-1 component would address prandial. What's the rationale for why that would not be the case? |
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Post by peppy on Nov 17, 2015 13:13:51 GMT -5
The disappointing impression I got from the SNY CC was that Lixilan alone would be the first line treatment, based on the assumption that the GLP-1 component would address prandial. What's the rationale for why that would not be the case? Reply; type two perhaps. Type 1 Approximately 1.25 million American children and adults have type 1 diabetes. LixiLan, single-injection combination of Lyxumia® and
Lantus® in Phase III development for Type 2 diabetes
LixiLan is the fixed-ratio combination of Lyxumia® with Sanofi’s
Lantus® (insulin glargine), the most prescribed basal insulin
world-wide, in development for administration as a single daily
injection via a disposable pen.
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Post by rrtzmd on Nov 17, 2015 13:21:09 GMT -5
From the post directly above; It does not have anything to do with afrezza. Afrezza is not human insulin! It is afrezza -- human insulin encapsulated in FDKP particles. When its application is filed, it will have to be for the drug, afrezza. Fourth post in this thread; Some people think this application is for Afrezza and that Sanofi has been granted anonymity by the EMA. If so, the decision to authorize will be made within 45 days, if no issues remain unresolved. There are many people who think that this EMA case is NOT related to Afrezza (such as the use of "biosimilar" in describing the drug) but I think we should be able to put the debate to bed soon. 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. |
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Post by bradleysbest on Nov 17, 2015 14:43:16 GMT -5
Did we ever learn what Matt whispered to Al earlier this year at the meeting they had. I don't know if that was the same meeting that Al talked about his wifes migranes. But Al spoke out of turn and Matt quickly told him we haven't divulged that or we haven't disclosed that yet. Anyone remember? Whatever it was it still has not been announced! |
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Post by kbrion77 on Nov 17, 2015 14:48:34 GMT -5
Did we ever learn what Matt whispered to Al earlier this year at the meeting they had. I don't know if that was the same meeting that Al talked about his wifes migranes. But Al spoke out of turn and Matt quickly told him we haven't divulged that or we haven't disclosed that yet. Anyone remember? It's the infamous "rights to our new process" quote. Just another unknown that might or might not come to the light of day someday. |
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Post by jeremg on Nov 17, 2015 14:49:09 GMT -5
Did we ever learn what Matt whispered to Al earlier this year at the meeting they had. I don't know if that was the same meeting that Al talked about his wifes migranes. But Al spoke out of turn and Matt quickly told him we haven't divulged that or we haven't disclosed that yet. Anyone remember? Sweet nothings. |
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