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Post by Clement on Sept 24, 2018 11:40:41 GMT -5
Mike C was asked by an analyst about the FDA path ahead for TreT. In Mike's answer, he said "in a phase 1 clinic". What did that mean?
Edit: The reason I ask is I thought TreT was finished with Phase 1 and going directly into Phase 3.
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Post by sportsrancho on Sept 24, 2018 12:23:46 GMT -5
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Post by sportsrancho on Sept 24, 2018 14:17:56 GMT -5
Good Luck Longs. I really feel something good will come from this tomorrow! Thanks Jeff, you called it!! And thanks for reminding us all to pay attention!
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Post by mnholdem on Sept 24, 2018 14:39:46 GMT -5
Sorry there was no shout box but liane was unavailable and I was participating in a conference call at work while Mike C was presenting.
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Post by sportsrancho on Sept 24, 2018 15:03:01 GMT -5
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Post by Deleted on Sept 24, 2018 15:08:08 GMT -5
Mike did a good job today. Got to use his science / tech knowledge. Showed how Technosphere can cast a wide net in terms of Rx to load on it.
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Post by mango on Sept 24, 2018 15:45:00 GMT -5
Can someone give a detailed report? Did Mike or anyone else allude to the other UT/MannKind Technosphere applications?
I’ve noticed vaccines mentioned couple times now in the slides. Many of today’s vaccines are totally unsafe. Maybe the TechnoVax partnership will resurface someday in the future.
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Post by ilovekauai on Sept 24, 2018 15:59:40 GMT -5
I've been traveling and out of the loop, but getting caught up now. Nice what's happening. Ever since meeting Michael C and Dr. Kendall at the ASM last May, I've been much more at ease with my investment here. I can wait this out no matter how long, and no worries. Things are definitely looking up IMO despite the same old writers trying to say otherwise. I pay them no heed or respect because they aren't genuine, in my book at least. Stay strong true longs. Aloha!
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Post by Deleted on Sept 24, 2018 16:03:12 GMT -5
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Post by agedhippie on Sept 24, 2018 17:13:29 GMT -5
Johathan Rigby (Pres and CEO SteadyMed) was talking about the Trevyent Patch Pump. By the way, he is a diabetic and uses an insulin pump. He claims insulin infusion pumps are not water resistant and you can’t shower with them. Is this correct? (He uses one so he should know.) If so this is a huge benefit for Afrezza (vs. a pump) but I don't recall anyone mentioning this. If it isn't true than how can Rigby say this? He mentioned it because currently some PAH patients are using an insulin pump because there currently are no fda approved percutaneous pumps designed for PAH. Patch pumps are usually waterproof (the Omnipod is certified IPX8), and the newer Medtronics pumps are also rated the IPX8. Tandem is only IPX7. The bigger problem is the CGM sensor, after about 30 minutes you can get water between the sensor and the transmitter. Traditionally with non-patch pumps you uncouple them and put them somewhere dry before you shower and replumb them afterwards. With new pumps that not as necessary, but on the other hand you don't have anything to attach the pump to in the shower.
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Post by sayhey24 on Sept 24, 2018 17:55:24 GMT -5
uvula - The problem with the T1s is they need both prandail and basal insulin. For the basal they are either taking a lantus, toujeo, tresiba, etc or use a pump.
If you listened to the Q&A Mike answered one of the questions by saying afrezza users combine the pump with afrezza use.
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Post by sportsrancho on Sept 24, 2018 17:56:30 GMT -5
From Gary... Who gives the best reviews.
Mike's presentation directly followed Johnathan Rigby's the CEO of SteadyMed which was intersting as because Johnathan's presentation started by him disclosing he is a diabetic using an insulin pump and how bad insulin pumps are. Interesting issues he said included the fact that titration had to be adjusted by the doctor in office as well as the fact they aren't waterproof. He displayed a schematic of the pump SteadyMed is working with United Theraputics with and frankly it seemed complicated and fragile. It seemed the perfect set up for Mike. Mike's presentation was specifically designed to showcase TS as a superior drug delivery platform. In his presentation he disclosed prelimiary study information that UT approved in regards to TS in a number of 6 cohorts where TrepT was tested and had superior results over anopther PAH drug. More detailed information about that will follow. Mike also discussed the superiority of TS over other inhalation dry powders. He discussed the way TS was bonded with other drug formulas using an acid bonding process that creates a better absorption percentage through the lungs. Goldman Sachs and JPM had follow up questions. Mike hit it out of the park. He was on his A game. Might be why the stock ran up today.
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Post by uvula on Sept 24, 2018 18:33:04 GMT -5
To add to the above comments, the pump works continuously for 48 hrs and is then replaced. They didn't mention if they were recycled by the factory or you just throw it out. Sounds expensive/wasteful. The drug volume is pretty small. My guess is 10cc/day. Apparently all batteries expand when they are being discharged and the pump uses the swelling of the battery to force the drug out of a small bladder. Seems like a novel and clever way to accurately dispense small volumes.
I think the reason the other treatments use an IV or a pump because the drug needs to be continuously put into the patient. I might be wrong about this.
The big unknown to me is how TrepT can deliver a constant and continuous supply of the drug. The trial used healthy patients so this wouldn't really be an issue for the trial. I don't think Mike mentioned anything about this. I'm sure there is a good answer, I just don't know what it is.
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Post by falconquest on Sept 24, 2018 18:54:44 GMT -5
Great presentation. IMHO the biggest takeaway is that both Trep and trevyent can coexist to give patients more options. Some FUD types claimed that UT did the deal with MNKD just to keep Trep from ever coming to market. One question that wasn't answered was how long a Trep puff treatment will last. Will the patient have to puff every 10 minutes 24 hours a day? Ribgy said that current PAH users on the pump need to have access to a backup pump 24 hrs a day in case the pump they were using failed. This makes it sound like when a pump fails the patient is in trouble right away. Rigby is a great speaker. By comparison Mike sounds like he is mumbling. Slow down and annunciate. And stop trying to be funny. That would be "enunciate". He needs to practice his "round the rugged rock the angry rascal ran" & "she sells sea shells by the seashore" more. A basic acting class would help with public speaking. It is important to speak clearly and with authority in his position. Mike needs to convince others that "we get it an you don't, but I'm going to tell you clearly and professionally". He should know that coming from a marketing background. He is Mannkind and should d-e-m-o-n-s-t-r-a-t-e that.
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Post by patten1962 on Sept 24, 2018 20:24:02 GMT -5
Good Luck Longs. I really feel something good will come from this tomorrow! Thanks Jeff, you called it!! And thanks for reminding us all to pay attention! You get the credit. You are awesome!
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