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Post by dreamboatcruise on Apr 27, 2018 12:06:23 GMT -5
They've already provided sound data on having the fastest pk/pd profile... and it was approved by FDA and included in prescribing lit. It's just that the FDA doesn't appear to yet want to define whether a new designation/class is needed and if so what the threshold for qualifying should be. I don't think any new data from STAT or otherwise would change whether/when FDA will decide on a new designation. It's not the STAT study or any open study that will convince the FDA to reverse it's ruling on the sNDA submitted by MannKind. It will be Dr. David Kendall, quite possibly with backing from the American Diabetes Association and other key opinion leaders. I'm also expecting a major medical journal publication about Afrezza within the next 3 months. Novo as well is likely pushing to have a new designation, of course defined such that Fiasp qualifies. If the ADA were to weigh in on this, that might carry weight with the FDA. As I learned long ago, trying to predict what and when the FDA does things seems to be a fools errand. My point is simply that the speed of Afrezza has already been proven and accepted by the FDA... as demonstrated by Peppy often posting the PD table in Afrezza lit compared to the one in Fiasp lit. Personally, It isn't clear to me that being called "ultra-rapid" would really change much, unless as some have suggested, it would change how insurance formularies treat Afrezza. The table already makes it pretty clear to patients and doctors that Afrezza is far faster than other prandials.
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Post by dreamboatcruise on Apr 26, 2018 21:21:15 GMT -5
It appears like there are a lot of moving parts in the diabetes world right now with CGMs becoming more and more accepted. Maybe the STAT study can show what an Ultra-Rapid Acting insulin can do and this will help turn the tides on a new designated class of insulin. That's what I am thinking too. Afrezza and Aspart are both classified as rapid acting insulins so according to FDA they should both deliver similar results, correct? What STAT will reveal is that is incorrect: #1 Afrezza physiologically mimics endogenous human insulin secretion, it is not even "ultra rapid" it is simply providing the same insulin any other person without diabetes has and mimicking the first-phase release that is lost. Afrezza mimics human insulin because it is human insulin. Is does what insulin does because that's what it is and what it is suppose to do. #2 Aspart is not even insulin. Proline was taken out of the B28 position and replaced with aspartic acid which does not even exist in neither A nor B chains of human insulin amino acid sequences. It does not mimic insulin because it is not insulin. It is an altered foreign protein. STAT is real time evidence that Afrezza mimics endogenous insulin secretion. No I don't believe that is a correct assumption. New drugs with better efficacy often are designated in the same class as older drugs that are less effective. I believe there would have to be some other reason justifying a new designation. In the case of speed of action in insulins it may be that a new designation would help with patient understanding and correct use of the product... that might be the compelling reason to create a new designation, but still the thorny issue is how does one draw the line when in reality the speed of action is a continuum.
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Post by dreamboatcruise on Apr 26, 2018 20:03:04 GMT -5
Doesn’t that make you wonder what’s been submitted? With the shenanigans that happened at the FDA during the first and second CRLs and the fierce competition MannKind is facing from the established BPs, I would not tell a soul what I had up my sleeve. My hope is that the STAT study is sound enough along with all of the 60 or more older studies that they can apply to have the label upgraded to Ultra Fast Acting. We will see. They've already provided sound data on having the fastest pk/pd profile... and it was approved by FDA and included in prescribing lit. It's just that the FDA doesn't appear to yet want to define whether a new designation/class is needed and if so what the threshold for qualifying should be. I don't think any new data from STAT or otherwise would change whether/when FDA will decide on a new designation.
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Post by dreamboatcruise on Apr 26, 2018 15:03:59 GMT -5
Wonder if we'll get an announcement of Q1 earnings release date sometime tomorrow, or Monday.
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Post by dreamboatcruise on Apr 26, 2018 14:51:03 GMT -5
My shares were always 100% loaned until just the last few weeks. Something has changed. Yes, 14M shares were recently sold by MNKD but that was not the first dilution in the last few years. When the 10M shares were sold last year at $6, my loaned shares were not returned. They make good profit on the spread between the interest they pay vs the interest they charge, so I don’t know what you mean when you say “Fidelity is very conservative”. I have never seen shares available to short MNKD when trading on the Fidelity platform in over three years. MNKD was not the only stock either. I was never able to locate them either via customer service. IB and Lightspeed have made shares available over the last year. it is just an observation when I was trading with them versus other brokers. In my opinion only the institutions can short MNKD at Fidelity due to policys from their risk department. In talking to the share loan department at Schwab long ago they said something about Fidelity usually paying higher interest because they loaned to hedge funds whereas Schwab did not. FWIW
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Post by dreamboatcruise on Apr 26, 2018 14:44:24 GMT -5
You’re right I am not, I never go to LA, I try to stay as far away from there as possible. In conclusion, the 405 freeway is a glorified parking lot unless you're traveling in the middle of the night. I recommend getting the Waze app for navigation in Los Angeles.
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Post by dreamboatcruise on Apr 26, 2018 14:42:42 GMT -5
I don't believe that Fidelity wants its retail clients to short MNKD, so they keep it HTB. For the most part Fidelity is very conservative My shares were always 100% loaned until just the last few weeks. Something has changed. Yes, 14M shares were recently sold by MNKD but that was not the first dilution in the last few years. When the 10M shares were sold last year at $6, my loaned shares were not returned. They make good profit on the spread between the interest they pay vs the interest they charge, so I don’t know what you mean when you say “Fidelity is very conservative”. And none of my shares on loan now at Schwab. If/when the interest ticks up I plan to call and be the squeaky wheel. Something has changed, but we really can't know what until the next short interest numbers are out.
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Post by dreamboatcruise on Apr 26, 2018 2:52:47 GMT -5
Gosh NO, didn't Apple just buy Mannkind That would be a very positive turn... like me winning the lottery. Me thinks you ran across very, very old news.
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Post by dreamboatcruise on Apr 26, 2018 1:34:56 GMT -5
Of course, if you're a phony Beazer may have an entirely different reaction. I'm sure that just means he's a fireman. Hydrant?... man?... he's a puppy.
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Post by dreamboatcruise on Apr 26, 2018 1:19:08 GMT -5
This is what stood out to me: "Readying themselves to get the word out about Afrezza in a much bigger way, they wanted to familiarize us with the product and learn from us how they should use social media.
As a small company devoted currently to one product they are the “David” amongst the “Goliath” pharmaceutical companies ike Novo Nordisk, Lilly and Sanofi. But expect to be hearing about them over the coming months."
Where is the money from the Medici family to breath life into our bronze David?
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Post by dreamboatcruise on Apr 26, 2018 0:51:40 GMT -5
That whole thing was staged long ago. David only trained the bear to make it look like he was in peril, in order to impress a young nurse (now his wife). I hear he's been training another bear at his cabin in northern Minnesota to impress his children on how tough he is. I think he's also planning to invite his daughter's new boyfriend to scare the crap out of him. I think he wants her to marry a doctor. "Stage right... is that my right or your right?" "I'm stressed about trying to motivate this 'angry' thing. 'Grrrr!'... just doesn't... feel right. I've had a pretty good life for a bear... not sure what I should pull from. Could I just do sad? If I think about The Champ, I can usually cry."
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Post by dreamboatcruise on Apr 26, 2018 0:41:35 GMT -5
Is car rental necessary? Train? Bus? Taxi? Walk? Is LAX the best airport to fly into? There is no train or bus service from LAX to Thousand Oaks and if there is, it would take all day. Fly into Burbank or LAX. Burbank would be easier traffic. Oh my god, I nearly died laughing. You are hysterical. Train service from LAX to Thousand Oaks? Please tell me you're playing The Laugh Factory soon. OMG, you didn't just say that I'm crying. Stop it!
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Post by dreamboatcruise on Apr 26, 2018 0:33:55 GMT -5
The wording from MNKD makes it sound like it wasn't new (or old) clinical data, but rather a determination that what needed to be communicated has been. Seems a bit strange that would be the case, but that's what it appears to say. The REMS required communication of the bronchial spasm risk, what had to be sent, and who it had to be sent to are in this letter - REMS - FullFrom the FDA letter: We have determined that the communication plan is no longer necessary as an element of the REMS to ensure the benefits of Afrezza (insulin human) inhalation powder outweigh its risks because the communication plan has been completed and the most recent assessment demonstrated that the communication plan has met its goals.The communication is complete therefore the plan is no longer needed, therefore the REMS (which was that " MannKind Corporation will implement the following communication plan to healthcare providers likely to prescribe AFREZZA") is also complete, and rather obviously no longer required. Perfectly straight forward, and does not require any fantasies about nebulous clinical data Darn... I like fantasies... dreaming about kissing a prince and having him turn into a lizard.
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Post by dreamboatcruise on Apr 25, 2018 20:03:11 GMT -5
My question for Dr. Kendall would be what data was submitted with the sNDA that allowed the FDA to make the decision a REMS is no longer required? Was it from the 60+ lost studies or clinical results over the last 3 years or both? The wording from MNKD makes it sound like it wasn't new (or old) clinical data, but rather a determination that what needed to be communicated has been. Seems a bit strange that would be the case, but that's what it appears to say.
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Post by dreamboatcruise on Apr 25, 2018 18:21:55 GMT -5
Folklore has it Dr. Kendall once wrestled a grizzly bear with one hand tied behind his back while dictating an abstract for an ADA presentation. That one is just too crazy to not be true While eating a mallomar that Spiro gave him. I saw the youtube video and it was epic! And I heard at one trade show he picked up two cases of mallomars and leapt over an entire 20x20 booth in a single bound in order to illustrate what a glucose spike is to an endo that didn't understand.
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