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Post by compound26 on Dec 3, 2015 17:13:52 GMT -5
Remember how Shkreli got involved by interfering with the FDA, which led to the second CRL and another half $billion in development costs?
Perhaps Sanofi is prudent and keeps a lid on things because they know that not only shorting hedge fund managers but many direct pharmaceutical competitors would also try to interfere if they were to know Sanofi's game plan... MN, I do not know if your comment was directed to me, but just in case. When I say I would like a bit more clarity I do not mean from Sanofi. It would be nice to know what they are planning, but I understand their concerns and why they do not feel compelled to share anything. On the other hand, I do feel like Mannkind could lift a huge weight from our shoulders by clarifying a bit more what their financial situation is, and how if any it is affecting future development of other TS apps. I feel the longer they go without saying anything the longer and more ingrained the perception that they are in serious trouble will dominate the events. Personally, I am now thinking 2 to 4 more years before we see MNKD really do well in our portfolios. My concern is how they are going to cope financially and what will need to be sacrifice if any. I am sure there is a plan, I just would like them to, at least, give us some pointers. As long as Sanofi has a strong commitment, Mannkind will find ways to finance the gap (from now till Afrezza ramp up). Sanofi buy in (a minority interest) or provides a loan are certainly among many of the options there. I agree with Stevil that "SNY will dump obscene money into making sure Afrezza is successful if they choose to stick with it. SNY needs something big right now, and while I don't think they're quite desperate, they probably aren't far off. SNY needs something big to stay a market leader." Their PPS has dropped about 15% in the last month and they now do not have a product to maintain their market leader position in the insulin market. I do not think they can count on Tuojeo to be able to fend off Tresiba. And now all kinds of evidence suggesting that Sanofi has a strong commitment. The 500 people trial where Afrezza is used (which trial won't end until 2017), the three post-marketing trials being completed/recruiting, with the pediatric trial requiring CGM (hinting of collecting of additional data for use by Sanofi), the November Vegas training of reps people rumored about, continuing print media DTC (latest is the December issue of Good Housekeeping, which supposedly reaches an audience of 24 million each month), recent start of mass direct mailing in select markets (CA, Florida, etc.), and now this advisory board meeting with early adopters of Afrezza (and probably also certain prescribing physicians, as we know that Dr. Steven Edelman prescribes Afrezza). |
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Post by bill on Dec 3, 2015 17:18:08 GMT -5
This is all pretty incredible. SNY needs to clean up the dosing issues. After a few months experience, my guess is that the dosing will be different for everyone. As has been mentioned, some people seem to need more than was required by injection. We wouldn't know since my husband didn't used insulin prior to Afrezza. However, we did need to fool around with the dosing at first as his blood sugar levels did not respond as we originally hoped. The coach program gave us "permission" to start the dosing 15 minutes after starting a meal. After that, he even required less over the first 3 months. So my guess is that the dosing problems and timing may have something to do with some people requiring more. After they figure it out, they might need less. Overall though, it seems more of an art than a science. While we were very comfortable with playing around with it until we got it right, I suspect some type 1s who are fearful could shy from that kind of uncertainty. If the SNY meeting with first users helps iron these issues out, it is all good! From what I've read and heard on the videos, while the dosages may vary, the algorithm may be identical for everyone. Here's my take. My primary assumption is that each individual's blood glucose reaction to different types of meals is consistent and the optimal Afrezza dosage for all the different types of meals falls into a modest number of Afrezza dosage solutions. The data to determine which meals need which solution type is ideally determined by using a CGM. I would expect that most meals would fall into one of two basic categories; a single dose of a particular strength, or an initial dose with a follow-on dose (~90 minutes later?). The other variable would be the strength of the dose; 4U, 8U, or 12U, or a higher combination. The strength of the first dose should be the lowest dose that avoids the initial blood glucose spike. If the initial spike is avoided but a secondary spike occurs then that type of meal would require a follow-on dose. Once again the follow-on dose would be the smallest dose that avoids a spike once you know that a certain type of meal requires an initial and follow-on dose. I think one could start out by assuming that any follow-on dose will normally be equal to, or less than the initial dose. That's it... Figure out which types of meals need the single and dual dose solutions. Then figure out what cartridge strength is appropriate for the different meal types. If you're right, no spike. If you're wrong and you spike, then you adjust the next time you have that type of meal. All of the above assumes that most individuals tend to consume similar types of meals, most of the time. T1s are probably best equipped to follow the algorithm since they're already using algorithms with their injectables. Many T2s will be starting from scratch and may benefit from "borrowing" a CGM for a few months to figure all this out. Otherwise, they'll need to use test strips to work through the calibration process. I hope the above isn't way off the mark, but I hadn't seen any algorithm actually written out and thought I'd give it a try. Apologies in advance if I've messed anything up. |
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Post by dreamboatcruise on Dec 3, 2015 18:47:45 GMT -5
Evening--my first thought would be they don't want to tip their hand to Sanofi as to the options they are considering...especially if such info might lessen or possibly worsen their already weak negotiating position w Sanofi. In all likelihood there are no negotiations occurring between MNKD and SNY. |
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Post by kball on Dec 3, 2015 18:59:29 GMT -5
Evening--my first thought would be they don't want to tip their hand to Sanofi as to the options they are considering...especially if such info might lessen or possibly worsen their already weak negotiating position w Sanofi. In all likelihood there are no negotiations occurring between MNKD and SNY. Really? If you're Al, it would seem to me you would be looking at any and all alternatives to improve your companies outlook and that would include revisiting existing relationships, and cultivating new ones just in case. I could certainly be wrong but that's where his focus has to be at this point. What's left? |
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Post by dreamboatcruise on Dec 3, 2015 19:15:23 GMT -5
kball... hopefully something on the TS front.
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Post by bill on Dec 3, 2015 19:16:41 GMT -5
Another major focus for MNKD right now is likely to be their search for a new CEO. That could be occupying a lot of Al and Matt's time.
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Post by rockstarrick on Dec 3, 2015 19:22:16 GMT -5
Inhaled via the lungs is one of the greatest advantages of afrezza. !! Where else would you inhale it to ?? This was the plan from day 1, "Inhaled Insulin". NO NEEDLES !! Carbon coated "human insulin"
Diabetics inhaling Carbon, the 6th most abundant element on Earth + human insulin for almost a full year, with literally no adverse health affects SO FAR, actually, there have been documented health benefits. Normal liver function tests, Retinopathy reversed, Insulin resistance reversed, Charles Lacy reports no more asthma after starting afrezza off label due to having asthma. I don't know where you have been getting your information from, but what you are commenting about has never been an issue. Can you provide a source to prove people are discontinuing afrezza ?? Your question why so many samples but not many scripts will soon be answered IMO. Good Luck to all This is not correct, or way oversimplified, or something.... misinformed.... I will stick with not correct.... Afrezza is definitely not "carbon coated" insulin. And the abundance of carbon on Earths surface (C is definitely not that common in the solid Earth) has nothing to do with its safety to humans. This is really just a misinformed post. One star out of five. I stand corrected, Sorry for the misinformation Cathode, I was sure I read an article about a carbon coated inhibitor, but after looking for the article for hours, I realize I was wrong. It would be the Hydrogen activity, (pH) that enhances the adsorption process of the FDKP particles to the insulin, and the disassociation of these particles when reaching the pH of the lungs. Can I get a few stars for pointing out the unexpected benefits of afrezza, and admitting I was wrong ?? Thank you for clarifying my inaccurate comment. |
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Post by kball on Dec 3, 2015 20:11:48 GMT -5
kball ... hopefully something on the TS front. Hope so. Trying to remember, weren't about 35-40 employees working on TS a few months ago? With the recent layoffs I'd be very interested to know what those numbers are now and how much they were affected. Anyone have any insight? btw--was in Del Mar Monday. Lovely area. Bet Sam hits the beaches there. (Sam if you happen to read this theres a great mens clothing store called Durantes there). |
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Post by EveningOfTheDay on Dec 3, 2015 20:25:04 GMT -5
I agree with Stevil that "SNY will dump obscene money into making sure Afrezza is successful if they choose to stick with it. SNY needs something big right now, and while I don't think they're quite desperate, they probably aren't far off. SNY needs something big to stay a market leader." Their PPS has dropped about 15% in the last month and they now do not have a product to maintain their market leader position in the insulin market. I do not think they can count on Tuojeo to be able to fend off Tresiba. And now all kinds of evidence suggesting that Sanofi has a strong commitment. The 500 people trial where Afrezza is used (which trial won't end until 2017), the three post-marketing trials being completed/recruiting, with the pediatric trial requiring CGM (hinting of collecting of additional data for use by Sanofi), the November Vegas training of reps people rumored about, continuing print media DTC (latest is the December issue of Good Housekeeping, which supposedly reaches an audience of 24 million each month), recent start of mass direct mailing in select markets (CA, Florida, etc.), and now this advisory board meeting with early adopters of Afrezza (and probably also certain prescribing physicians, as we know that Dr. Steven Edelman prescribes Afrezza). We would have to establish what an obscene amount of money is, but I do fully agree with the basic premises of your statement. I do think that Sanofi's current situation is somewhat desperate, and I do think Sanofi realices that Afrezza could offer a big edge for years to come, especially if they start developing around the clear advantages Afrezza offers, so now that we have established that Sanofi is not going anywhere, as I have maintained again and again, and regarding the first part of your statement, all I can say is that I wish I had your faith. I understand Mr. Mann will most likely intervene to prevent MannKind from going bankrupt, but his last intervention represented a substantial dilution to the sp at the cost of the shareholders. As a private citizen I have a personal interest in Afrezza succeeding at any cost because of people very dear to me could benefit from it, but as an investor I much rather if whatever solutions Mannkind finds to refloat its finances do not hugely affect my bottom line. I have no doubt that you are right when you say that Mannkind will find alternatives, although I have my doubts that, at least for the moment, those alternatives include a buy in from Sanofi (I believe Sanofi will be ready to do this when Afrezza is proven a success or in its clear way to success). Without farther guidance from the company, we are left to speculate but it is my belief that the most likely outcome is a secondary offering. For how much and how much this will dilute the value of the shares we hold is something that remains to be determined. In the very long run this might not matter much, but it certainly will in the short medium term, which, again in the short medium term, has the ability of making me pretty unhappy with the situation. Now, if I am wrong, which is very possible, I would like to know it sooner rather than later. I fail to see how a detailed disclosure from Mannkind regarding future financing is something Mannkind can not provide, other, of course, than if they simply have no options at the moment and are pinning their hopes, just like us, on the quick success of Afrezza. If this is the case, I remain fairly uneasy. |
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Post by patryn on Dec 3, 2015 20:26:12 GMT -5
kball ... hopefully something on the TS front. Hope so. Trying to remember, weren't about 35-40 employees working on TS a few months ago? With the recent layoffs I'd be very interested to know what those numbers are now and how much they were affected. Anyone have any insight? btw--was in Del Mar Monday. Lovely area. Bet Sam hits the beaches there. (Sam if you happen to read this theres a great mens clothing store called Durantes there). Man I hope you got some sun on Monday. Your complexion is a bit pale but your eyes look great! |
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Post by cfield23 on Dec 3, 2015 23:42:59 GMT -5
EOTD - I think that a secondary offering may be necessary, unless upfront $$$ is received from a TS partner (or more than one TS partner). If there is no partnership announcement within the next 3Qs, it's also possible that share price may be substantially higher than it is now, so an offering may not cause much dilution. It may be a moot point, as Sanofi may begin pushing Afrezza in a big way, ending all doubts and sending shorts to the exits.
BTW - earlier comment was not directed at you. I just posted a thought for everyone to consider.
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Well, I'd better get back to watching rival Green Bay get spanked (ahem) I mean, play a valiant game against the Detroit Lions.    I'm hoping my Minnesota Vikings will gain a few more games above the Packers now that we're leading the NFC North... All Day 28 is on pace to once again challenge Eric Dickerson's NFL single season rushing record and our defense is playing very well.
ahhhh so that's what the "mn" in mnholdem is for. Did you happen to go to the U of Minnesota? If so, Ski U Mah!! If not, well I did, so Ski U Mah anyway. Go gophers! |
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Post by brentie on Dec 3, 2015 23:46:44 GMT -5
EOTD - I think that a secondary offering may be necessary, unless upfront $$$ is received from a TS partner (or more than one TS partner). If there is no partnership announcement within the next 3Qs, it's also possible that share price may be substantially higher than it is now, so an offering may not cause much dilution. It may be a moot point, as Sanofi may begin pushing Afrezza in a big way, ending all doubts and sending shorts to the exits.
BTW - earlier comment was not directed at you. I just posted a thought for everyone to consider.
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Well, I'd better get back to watching rival Green Bay get spanked (ahem) I mean, play a valiant game against the Detroit Lions. I'm hoping my Minnesota Vikings will gain a few more games above the Packers now that we're leading the NFC North... All Day 28 is on pace to once again challenge Eric Dickerson's NFL single season rushing record and our defense is playing very well.
ahhhh so that's what the "mn" in mnholdem is for. Did you happen to go to the U of Minnesota? If so, Ski U Mah!! If not, well I did, so Ski U Mah anyway. Go gophers!  |
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Post by cfield23 on Dec 3, 2015 23:54:54 GMT -5
ahhhh so that's what the "mn" in mnholdem is for. Did you happen to go to the U of Minnesota? If so, Ski U Mah!! If not, well I did, so Ski U Mah anyway. Go gophers!  Well, I'm from Massachusetts, so the only 12 I care about is the best of them all. No debate. TB12 = GOAT. Go Patriots. |
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Post by mssciguy on Dec 4, 2015 0:00:11 GMT -5
@cfield123 my wife is a Brady fan, so she has a 12 shirt, and just told me she'd get me a 12 Rodgers shirt.
The final play was the very best I've ever seen.
Just like MNKD will do shortly
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Post by trenddiver on Dec 4, 2015 1:49:22 GMT -5
Evening--my first thought would be they don't want to tip their hand to Sanofi as to the options they are considering...especially if such info might lessen or possibly worsen their already weak negotiating position w Sanofi. In all likelihood there are no negotiations occurring between MNKD and SNY. I'm not sure that is factual, but negotiations maybe occurring sooner than you think. |
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I'm hoping my Minnesota Vikings will gain a few more games above the Packers now that we're leading the NFC North... All Day 28 is on pace to once again challenge Eric Dickerson's NFL single season rushing record and our defense is playing very well. 
