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Post by peppy on May 10, 2017 20:15:17 GMT -5
The Uppy The only thing that changed.
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Post by peppy on May 10, 2017 20:19:01 GMT -5
My suggestion Dubai City in the United Arab Emirates
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Post by Deleted on May 10, 2017 20:38:11 GMT -5
Your resident FUDster did not think the call was that bad. However, if you are down 99% and just watched the stock double and then some I can understand why this news would let you down.
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Post by Deleted on May 10, 2017 20:43:37 GMT -5
sophie "If Novo is also producing an Ultra rapid insulin and they too get that designation, it could make the label change insignificant." Novo doesn't product a rapid-acting insulin, it is an RRA.
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Post by ssiegel on May 10, 2017 20:47:46 GMT -5
Transcript from Matt's most important items: We're becoming more efficient and improving our financial position on a daily basis. Decreased our cash burn rate from 10M/Month to 7.4 M/month. Continuing to talk with Deerfield about restructuring some of those debt instruments. Lease expired in April and they signed a new lease on a less expensive corporate and commercial HQ facility in West Lake Villiage, CA, which is closer to the bio-pharma talent pool. Improving in international area. We are on file in one middle-eastern country. And in later-stage negotiations in a number of other different jurisdictions. You'll see announcements on that in the near term. Clearly, our cash position is better than it has been in most quarters in the past. We don't have everything we could possibly want. The cash we have today should take us comfortably into third quarter, but we estimate to get into the end of year will probably take us another 20 to 30 million beyond that. That said, I have no doubts and I am quite confident that we will have no difficulty raising that kind of money to get us to where we need to be. We've primarily been focusing on debt instruments recently because we have not been very happy with the SP, but rest assured we will do what it takes to keep Afrezza on the market and make it the success we all know it can be. I don't get it: "In May 2015, the Company entered into a sublease agreement with the Alfred Mann Foundation for Scientific Research (the “Mann Foundation”), a California not-for-profit corporation." So the foundation couldn't cut MNKD a little slack on the lease in order to help out?
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Post by peppy on May 10, 2017 20:49:05 GMT -5
sophie "If Novo is also producing an Ultra rapid insulin and they too get that designation, it could make the label change insignificant." Novo doesn't product a rapid-acting insulin, it is an RRA. www.diabetesdaily.com/blog/novo-nordisks-ultra-fast-rapid-acting-insulin-fiasp-approved-in-europe-and-canada-336078/
Fiasp will be available by vial, Penfill, and FlexTouch insulin pen. it has to be a POS
Pharmacodynamic effects Fiasp is a mealtime insulin aspart formulation in which the addition of nicotinamide (vitamin B3) results in a faster initial absorption of insulin compared to NovoRapid. The onset of action was 5 minutes earlier and time to maximum glucose infusion rate was 11 minutes earlier with Fiasp than with NovoRapid. The maximum glucose-lowering effect of Fiasp occurred between 1 and 3 hours after injection. The glucose–lowering effect during the first 30 minutes (AUCGIR, 0–30 min ) was 51 mg/kg with Fiasp and 29 mg/kg with NovoRapid (Fiasp/NovoRapid ratio: 1.74 [1.47;2.10]95% CI). The total glucose–lowering effect and maximum (GIRmax) glucose–lowering effect were comparable between Fiasp and NovoRapid. Total and maximum glucose–lowering effect of Fiasp increase linearly with increasing dose within the therapeutic dose range. The duration of action was shorter for Fiasp compared to that of NovoRapid, and lasts for 3–5 hours. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004046/WC500220890.pdf
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Post by ssiegel on May 10, 2017 20:51:12 GMT -5
You don't really mean "respectfully" do you? Actually, I meant what I said to sophie . At the first news of a new Ultra-Rapid-Acting insulin in Europe, I decided to learn about Fiasp. "Second-in-Class" simply doesn't carry the weight of "First-in-Class". I wanted to see if Novo Nordisk would beat MannKind to the punch in the USA. They won't, but when Fiasp becomes FDA approved they'll have a massive sales force and cash to market Fiasp here. MannKind needs to make some inroads with Afrezza before Fiasp gets here, IMO. The sales force won't be so much an issue as Fiasp having substantial trial data proving its effectiveness in a number of areas. That will likely translate into immediate insurance coverage. That is where the advantage will lie.
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Post by sayhey24 on May 10, 2017 20:52:13 GMT -5
Which is good but seems like everything else is just "wait and see"...again. If Novo is also producing an Ultra rapid insulin and they too get that designation, it could make the label change insignificant. As we're seeing now, being in the same class as RAA's is doing nothing for us because there are other options that docs like better with no reason to choose Afrezza over them. A saving grace would be if this other ultra rapid insulin behaves similarly and paves the way for an understanding of how Afrezza works, but even then, until a long term safety test is completed, I see little reason for a label change to improve sales if we're not the only drug in that class. Sophie - Dr Bode gave a very nice presentation last week at a Medscape Education session. He discussed "Faster Aspart". While he said it has 74% greater action in the first 30 minutes and twice as fast appearance in the blood stream thats not as good as afrezza. If afrezza gets the "Ultra" label, Faster Aspart will need to show non-inferiority to afrezza. Based on what was presented and the PK profile this will not be possible. Simply put afrezza has already obsoleted "Faster Aspart".
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Post by sophie on May 10, 2017 21:03:06 GMT -5
sophie "If Novo is also producing an Ultra rapid insulin and they too get that designation, it could make the label change insignificant." Novo doesn't product a rapid-acting insulin, it is an RRA. Peppy beat me to the link. What's an RRA?
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Post by sophie on May 10, 2017 21:13:45 GMT -5
Sophie - Dr Bode gave a very nice presentation last week at a Medscape Education session. He discussed "Faster Aspart". While he said it has 74% greater action in the first 30 minutes and twice as fast appearance in the blood stream thats not as good as afrezza. If afrezza gets the "Ultra" label, Faster Aspart will need to show non-inferiority to afrezza. Based on what was presented and the PK profile this will not be possible. Simply put afrezza has already obsoleted "Faster Aspart". I'm not necessarily disagreeing with you. In fact, personally, I do agree with you, I just don't know if the FDA will see it the same way. Afrezza's PK profile isn't news. It was available while applying for FDA approval. I suppose the reason Afrezza wasn't labeled Ultra-rapid is because MNKD didn't pursue it. However, we do know that Afrezza was only classified as non-inferior to RAA. It matters what metric they use. I think that unless the FDA is going to make 2 additional classifications, instead of just one, that Fiasp will be in the ultra-rapid classification. It's clearly not an RAA, yet it's "similar" to Afrezza, at least as similar as they're probably going to get with a sub-q. Not all RAA's take the same amount of time to work either. I believe Apidra is faster than the older novolog yet it's still in the RAA category. scroll down a little for the table to see what I mean. Not exactly apples to apples, but at least giving reasons to why I think the FDA would still allow it to get lumped in. www.uspharmacist.com/article/pharmacoeconomic-advantages-of-insulin-analogs
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Post by peppy on May 10, 2017 21:21:29 GMT -5
Sophie - Dr Bode gave a very nice presentation last week at a Medscape Education session. He discussed "Faster Aspart". While he said it has 74% greater action in the first 30 minutes and twice as fast appearance in the blood stream thats not as good as afrezza. If afrezza gets the "Ultra" label, Faster Aspart will need to show non-inferiority to afrezza. Based on what was presented and the PK profile this will not be possible. Simply put afrezza has already obsoleted "Faster Aspart". I'm not necessarily disagreeing with you. In fact, personally, I do agree with you, I just don't know if the FDA will see it the same way. Afrezza's PK profile isn't news. It was available while applying for FDA approval. I suppose the reason Afrezza wasn't labeled Ultra-rapid is because MNKD didn't pursue it. However, we do know that Afrezza was only classified as non-inferior to RAA. It matters what metric they use. I think that unless the FDA is going to make 2 additional classifications, instead of just one, that Fiasp will be in the ultra-rapid classification. It's clearly not an RAA, yet it's "similar" to Afrezza, at least as similar as they're probably going to get with a sub-q. Not all RAA's take the same amount of time to work either. I believe Apidra is faster than the older novolog yet it's still in the RAA category. scroll down a little for the table to see what I mean. Not exactly apples to apples, but at least giving reasons to why I think the FDA would still allow it to get lumped in. www.uspharmacist.com/article/pharmacoeconomic-advantages-of-insulin-analogssophie, in the nicest way, I think you are making stuff up.
Method of administration Subcutaneous injection Fiasp is recommended to be administered subcutaneously in the abdominal wall or the upper arm (see section 5.2). Injection sites should be rotated within the same region in order to reduce the risk of lipodystrophy.
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Post by blueice on May 10, 2017 21:24:16 GMT -5
The Middle East item is interesting, but of more interest is the change of control, lack of Mannkind branded DTC and now a move to Amgen's backyard. A lot of dots to be connected not the least of which is today's explosive volume....
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Post by mnholdem on May 10, 2017 21:40:23 GMT -5
Regardless of what happens tomorrow, today's "explosion" likely had the effect of raising the level of risk in the minds of traders who are shorting MNKD. Roughly 240% rise in share price in a week's time demonstrated just how quickly things can go bad for you if you decide to short this company. A single press release may spell disaster. I'm of the opinion that news of ex-U.S. sales is imminent and has been leaked, possibly discovered by savvy analysts with connections to a Middle East drug agency or two. Short interest traders have to be wondering the same thing. Good fortune to us all.
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Post by blueice on May 10, 2017 21:49:58 GMT -5
Regardless of what happens tomorrow, today's "explosion" likely had the effect of raising the level of risk in the minds of traders who are shorting MNKD. Roughly 240% rise in share price in a week's time demonstrated just how quickly things can go bad for you if you decide to short this company. A single press release may spell disaster. I'm of the opinion that news of ex-U.S. sales is imminent and has been leaked, possibly discovered by savvy analysts with connections to a Middle East drug agency or two. Short interest traders have to be wondering the same thing. Good fortune to us all. Good thoughts. I sense we will have more information in the next week. I think it would be a risky move for management to hold the ASM at this stage without material news. It would also be extremely arrogant to vote on compensation and such without a bigger incentive for justification. More news coming imo.
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Post by whale1r1 on May 10, 2017 21:50:13 GMT -5
Yes it is UAE, only requires FDA approval...60 day timeframe
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