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Post by esstan2001 on Jan 28, 2016 12:12:41 GMT -5
Great- now this CLOWN has a theory. This is not his theory its a lot of peoples concern While it may be a concern of yours and many people, the CLOWN states it is HIS THEORY (re-read the tweet).
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Post by esstan2001 on Jan 28, 2016 11:56:00 GMT -5
Words below from everyone's favourite streeter about Andrea Leone-Bay's departure: Great- now this CLOWN has a theory.
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Post by esstan2001 on Jan 26, 2016 16:43:33 GMT -5
The rumor can be a tool to drive some short covering. Why hold if there may be a higher, possibly multi-dollar offer that you are then forced to cover at.
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Post by esstan2001 on Jan 26, 2016 13:24:18 GMT -5
it was/is phase 1 a safety/dosage, trial. as near as I can tell. From the study: Secondary Objectives: To assess the ability to titrate the prandial and supplemental doses of Afrezza at each meal. To assess pharmacokinetics (PK) following a prandial dose of Afrezza in children ages 4 to 17 years with T1DM. It is here that I hope we can leverage our leeway into something useful to the label.
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Post by esstan2001 on Jan 26, 2016 12:58:28 GMT -5
Sanofi's interests are no longer aligned with ours- they can not be permitted to run this trial. As we take it back, I am hoping that the protocol can be amended in some manner to allow a test for superiority, to get a better indication on the label ASAP.
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Post by esstan2001 on Jan 26, 2016 12:30:04 GMT -5
... At that point it becomes questionable whether doing it as part of the pediatric study would have any merit vs simply doing it separately with all ages involved. It's amazing how easy it is to overlook reality (what we should know the FDA requires) in order to engage in wishful thinking, such as I did on hearing CGMs were involved in pediatric... I'm trying to learn lessons from past mistakes. The one thing we can still hope is that perhaps they clear up the dosing timing issue. If I'm correct about how they are blinding this test, they could still have each delivery route used at the appropriate time for its active ingrediant... injection 15 min before meal and inhale after start of meal. Hopefully. Though, perhaps the FDA really would want apples to apples to replicate adult trial. The reason I'd like to see another arm added to the study (I assume it has to stay pediatric, as it is titled as such) that could show superiority, is time.
To at least be able to claim superiority for kids by some time later this year, I think many PWD would assume hey, if it works better for kids, why wouldn't it also work better for adults... An adult superiority study is another study, more money, and has to get through the whole process (more time). Pedi is almost ready to run. I'd take a 2-3 month delay to get some superiority test into the trial. To me the faster we can make any better (even incrementally so) claims on the label, the sooner the fog lifts.
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Post by esstan2001 on Jan 26, 2016 1:23:31 GMT -5
Well, that's a bummer. When the initial details of the study were revealed some of us, including myself, were excited about CGM being mentioned... thinking erroneously that they might use the CGM to get optimal dosing and between meal corrections that might allow this pediatric study to be one with a superiority outcome. Sadly, CGM will not be used to dial in dosing and corrections. That study would then still be a ways off. Sanofi developed the protocol? Mannkind left holding the bag to finish up? They should at least be able to discuss amending the protocol with the FDA before it commences. Or run another arm of the study with CGM dosing feedback. Then try that with injectable- ha! that would show'em.
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Post by esstan2001 on Jan 25, 2016 9:35:46 GMT -5
The fact is loaning shares have facilitated shorts to crash sp to where MNKD has been unable to use the stock as a financial instrument. Shorts wanted MNKD to have to use their much needed cash to settle the notes and drive them closer to BK. So the idea that loaning shares is some sort of win win situation is extremely short sighted. It's been extremely detrimental to a struggling company Considering the proportion of institutional share lending to retail investor share lending, it is likely that you could pull all the retail loans of shares and it would be inconsequential to the price action of the stock. The real elephant in the room is the institutional lenders. Good luck convincing them not to loan (that will happen if / when prospects turn for Afrezza sales, or money comes into the company).
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Post by esstan2001 on Jan 24, 2016 15:33:36 GMT -5
I think you may be confusing blood glucose meters with CGMs because CGMs definitely are not free! Typically a Dexcom is around $650 for the receiver which is the bit you keep. The consumables for a CGM are the transmitter (a couple a year) and about 50 sensors a year. The attraction of a CGM is that you can tell if you are rising or dropping and how fast. This is a big deal because if I test at 140 before a meal I will take extra insulin to bring that down. With a CGM for example I could see that I am dropping quickly and rather than taking extra insulin I should to take much less or I will go low in a while. You can do without it, and I mostly do because of the cost, but it reduces my A1c by about 0.4 (6.6 to 6.2 last time) when I use it. I agree that if you are not on insulin, and the large majority of diabetics are not, it is of limited use. My point was, and maybe I wasn't clear enough, that blood glucose meters are free because the companies make lots of money selling strips. Whereas the insurance companies will never pay for cgms because of that reality. Many type 2s on insulin do not test nearly as often as type 1s and don't like to be hooked up constantly to a meter. While we all understand that the risk of hypis are as great for anyone on insulin, the reality is that they simply don't test as often. After the two weeks that it takes to adjust the Afrezza dose and become confident that there will be no hypoglycemia, the cgm becomes useless. Why would insurance companies pay for something that is only really needed for two weeks? You are making a case for leasing / renting the CGM in combination with Afrezza for the learning period- is this something insurance would consider supporting?
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Post by esstan2001 on Jan 24, 2016 14:59:53 GMT -5
I think that the massive short position in MNKD actually affects the sales of Afrezza. I, for one, would be reluctant to start using a new pharmaceutical product made by a company being bashed to death by shorts. What do you estimate as the number of patients and doctors that even know or understand what shorting is (pre, and post "The Big Short") Then of that percentage, how many do you think even know which company makes inhaled insulin, and of that segment, how many think it is Sanofi? IMO this is not too likely. Look to pricing, insurance coverage, tier, doc awareness, patient awareness... all the things Sanofi majorly dropped the ball on.
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Post by esstan2001 on Jan 24, 2016 14:54:37 GMT -5
A few foreign Afrezza partnerships should provide MannKind with sufficient cash for it not to be an issue. Agreed, but what's the hold up? The management team needs to starting making things happen. The reality is that it has been 19 days since Sanofi gave notice. In that short time, we have selected a CEO and established a TS deal, and are obviously working on getting Afrezza deals in place (foreign regional, clinics, and a US partnership). The urgency must be obvious to the CEO / CFO. Rome was not built in a day.
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Post by esstan2001 on Jan 23, 2016 12:45:14 GMT -5
.... The other risk in staying short is that at any moment, a celebrity, a politician, someone like Gates could easily sing the praises of Afrezza to a huge audience. That danger is there every minute of every day. There is, in my opinion, ZERO probabability that all the reports of Afrezza's effectiveness on social media are fake. Given that, how the #$% aren't shorts terrified that any one of the following things could happen at any moment: 1. What I described already in this thread. 2. A large sale to a country that accepts FDA approval (many) or a country that can do whatever the heck they want to (middle east, etc.). 3. A hedge fund intiating a squeeze mechanically to coincide with news or rumors, possibly of their own creation. The risk / reward seems so far on the risk side at 80 cents. risk side at 80 cents... for the shorts. Al seems to have many many wealthy friends- this includes Hollywood the entertainment industry. Nearly every Gala photo throughout the years, he is usually at the same table with Quincy Jones ($billions), he is friends with Danny DeVito, etc. I would think as part of a Hail Mary someone could convince Hanks & Perkins (a user) to do an advert stating how Afrezza is revolutionary advance in the treatment of D, and at the end state that they volunteered and did not get paid for this message. OK, time to stop dreaming :-)
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Post by esstan2001 on Jan 19, 2016 23:17:25 GMT -5
Was I dreaming, or was there some decision that a drug company could make claims as long as they knew them to be 100% factual; wasn't there some court case that permitted the company to make the claims and assume the risk or being wrong in the eyes of the FDA? I would think Mannkind would not want to be a guinea pig on this edge of the legal envelope issue, but maybe there are some hypo / speed superiority claims that can be made, assuming some smaller, affiliated clinical practices run some 3-6 month studies to validate the proper dose timing, etc. Get the data published / presented ASAP, while not an FDA run trial, the question is whether it could be used to make some type of claims... on results that are easier to demonstrate stat sig for. It was last year and in district court and at the time thought to be subject to appeal by FDA to Supreme Court. It was a company that had a valid scientific clinical trial for off-label use but didn't get FDA approval. Even if that is upheld I can't imagine that totally strips the FDA of their role in making standards about what is misleading and what isn't. I think they would still deem anecdotal stories as scientifically misleading. They force listing all the side effects because they demand balance as part of being non misleading. If you're showing individuals with the good results do you not think the balance would demand showing people that suffered the adverse effects? But if MNKD really wanted to stick their neck out the way to do it would be as you state. Do a short non-FDA sanctioned trial, and have marketing that does a very fair, sober representation of the trial data. Something else I was wondering about, that may help here- FDA maintains a Log of reported adverse patient events... Anyone seen the Afrezza reports, if they are as clean as I suspect (a few coughing issues) doesn't the FDA take that into consideration when a request for label revision is made? Is Mnkd at the point where this can be pursued? Afrezza has been available now just about 1 year now.
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Post by esstan2001 on Jan 19, 2016 12:43:41 GMT -5
If I were a diabetic I would rather trust the testimony of 200 other diabetics than any add with f#% actors and a smooth voice from the off. As a doctor I would also rather believe these testimonies than any sales rep. And a an afrezza user I would try to help MNKD to survive. Adverts aren't going to have 200 people. Do you trust every commercial that you see with one or a few people with some miraculous results? Would you trust a youtube channel for a miracle diet pill if they had 200 people give testimonials but you knew the website was owned and operated by the company that made the pills? Despite not serving Afrezza well, the FDA rules with regard to drugs are appropriate. People waste tons and tons of money (and in some cases endanger their health) because of the loose regulation of supplements that allow a few anecdotal results to be presented. We know Afrezza is a great drug, but the rules about marketing have to apply evenly to the good drugs and the not so good that may be marketed by the unscrupulous. Was I dreaming, or was there some decision that a drug company could make claims as long as they knew them to be 100% factual; wasn't there some court case that permitted the company to make the claims and assume the risk or being wrong in the eyes of the FDA? I would think Mannkind would not want to be a guinea pig on this edge of the legal envelope issue, but maybe there are some hypo / speed superiority claims that can be made, assuming some smaller, affiliated clinical practices run some 3-6 month studies to validate the proper dose timing, etc. Get the data published / presented ASAP, while not an FDA run trial, the question is whether it could be used to make some type of claims... on results that are easier to demonstrate stat sig for.
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Post by esstan2001 on Jan 14, 2016 17:38:48 GMT -5
wow I spit up my water when I got to that line :-) I try to only use that one on special occasions. I'll be good from here on out. Just can't believe I defended those crooks at Sanofi. Go Mannkind Well no one can contest that this event was worthy of special occasion status- damn them
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