Once again it's not insulin that is in the Oramed pill. It's another GLP-1, exenatide, insulin analog with all the speed of action problems and with the long tail of getting it out of the system problem. If it is not real insulin in the pill, it does not have the action of real monomer insulin that Afrezza does have in the body. Have you examined the results the Emisphere pill had with the GLP-1 from Novo? It did not even work.
Once Afrezza is on the market putting real insulin in the body, that will be the standard of care. All these insulin analogs will fall away over time due to all their fundamental problems as well as side effects plus they are injected.
This stock is a key and big supplier to Boeing for the 787 and the Airbus A350, but there are almost no posts on it or its composite business. Yet the stock is up big over the past year. I assume this must be almost all an institutional owned stock. Perhaps the next pop in price will come when the A350 starts taking production deliveries of composite products. I think that is in the Summer of 2014.
I watched this trade so close to $30 all day even though the close is not until March 2014. Seems like some players are speculating a higher buyout price is going to come from another company/PE fund/hedge fund. Perhaps with FDA approval it is worth a lot more than $30/share.
google this Reuters headline: IDB Group to sell Given Imaging stake for $426 million
That puts the price per share at $30 stated in the article.
Yes, and Google is operating like a publicly held company, which it is, that is controlled by just two primary shareholders. GOOG is doing better than just fine, thank you. I am just waiting on FDA approval which I know is coming. MNKD will do at least just fine. I pay no attention to kevinmik whatever his problem is.
I agree. He's become a joke to me. I no longer read anything he posts as the original poster, because he's a waste of time. I don't use ignore, and he's easy to skip anyway.
Well mann.ontop2, those other drugs that have been FDA approved with label warnings are not insulin before or after going into the body. Afrezza going into the blood stream is monomer insulin just like the pancreas outputs into the bloodstream. Whatever issues are going happen with Afrezza are going to be related to the carrier, the Technosphere. Most if not all safety issues with Technosphere in the lungs has been known and observed since the idea/concept of Technosphere. I am not aware of any safety issues flagged by the FDA in the past that have not been examined already. Maybe the FDA could ask for more testing, but that would be after approval and over time. They already have a lot of old Exubera users converted to Afrezza for looking at good safety results.
Based on what I see in the SEC disclosure, she still has 543,6451 MNKD stock options that she owns after this 25,000 option exercise in addition to the 112,756 actual common shares of MNKD she owns. She ain't hurtin'.
Yahoo posts appear to have lost their posting hierarchy ability sometime in the past day or two. redhaw_2000 I thus assume this quote and question is directed at my last post on this topic. "Whatever abbreviated trial MNKD is doing is being done on another maker of pure insulin to make sure its insulin monomer on Technosphere behaves the same way the Pfizer insulin monomer on Technosphere behaves." That was the complete thought, and as I think you know the latest phase III trials MNKD completed were done with Pfizer monomer insulin. If you are thinking something else, please explain.
So chrisdc73, as you know an RAA, rapid acting analog, is a synthesized few amino acid modification on the real insulin molecule. Yet the RAA still works with the insulin receptors in the human body with the actual desired property that the injected RAA remains as a monomer in the blood stream rather than a hexamer the way injected insulin does. The body can only react with monomer insulin, and that is why the RAA is called rapid acting.
So to the heart of what I think you are saying, to put an RAA rather than pure insulin on Technosphere to compare it to Afrezza would constitute an entirely new long set of FDA trials for efficacy as well as safety. That would be something MNKD would not agree to do. Besides the changes in the insulin molecule that created the RAA are the reasons the RAA does not clear out of the blood stream as fast as the monomer insulin Afrezza does. So such trials would be pointless.
Whatever abbreviated trial MNKD is doing is being done on another maker of pure insulin to make sure its insulin monomer on Technosphere behaves the same way the Pfizer insulin monomer on Technosphere behaves.
chrisdc73, I believe you are thinking correctly with your first question. There would be no reason for an RAA maker to attach its RAA to Technosphere in a trial, and I don't think MNKD would agree to do it anyway. I did some qualitative study of the chemistry of these things today, and I think whatever quick trials (for a partner?) MNKD has agreed to do it is to compare the insulin monomer of another manufacturer to the Pfizer insulin monomer MNKD has used in the current trials and the Pfizer insulin it has in inventory. I will have more inputs tomorrow when I hope I can get more time to post.
Besides manufacturing processes how widely varying could the chemical parameters be for human insulin? Yes, it is a complex molecule, but with the exception of purity levels what are allowed differences between manufactured insulins? Are some substitutions in the carbon chains present in some manufactured insulins? How does the FDA regulate various manufactured insulins if they are not essentially atom for atom the same structure?
I posted it as news, and I have no idea what the motivation behind Lilly's move is.
Google this headline to read the WSJ article from today.
Lilly Boosts Insulin Manufacturing Investment by $700 Million
Actually it says:
"Drug delivery and Formulation: oral delivery of poorly soluble drugs, protein formulations (focus: technologies addressing stability and reduced viscosity of high concentration formulations), s.c. sustained release of peptides, non-parenteral delivery of proteins/peptides, technologies enabling reduction of intravitreal injection frequency."
They said they have many aggressive regional potential partners, but they are holding them off until they get a plan for the USA. The assumption is they might be able to get both a good USA partner as well as a global partner in the same drug pharma company. If they do get the deal they want for the USA partner, but that partner does not want global then MNKD can go to the regionals or other pharma for a global ex-USA or simply cut a deal with one or more regionals. MNKD is hoping they can cut a deal for the USA and the global, but until they get the deal they want for the USA they are not going to cut a deal with a regional pharma. That was clear.
I see in the SA transcript all the questions came from analysts whose companies were named in the text of the transcript. That the operator did not call out their names and companies just indicates an unprofessional and maybe untrained operator was doing the monitoring of the call.
Not awesome. Just a patient investor who knows when he has latched on to a great company with a breakthrough biomedical technology that works and whose Phase III data says it works to FDA agreed endpoints. I make a lot of money finding these kinds of companies and betting big when I think I have the best hand. You can go all in, and I will be there calling you down.
Hey you post a lot for a guy who claims he owns just 1000 shares. I was just posting a fact in answer to a question. I own multiple 10s of thousands of MNKD, and I will be buying more at lower prices. I think I might get more tomorrow at lower prices, and I already posted some time ago I am happy to keep buying all the way down to the $3.80 level should it get there. At that point I would wait around to see if any of those gaps around 3 looked like they would actually get filled.