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Hexcel Corp. Message Board

dontdropyourlunch 83 posts  |  Last Activity: 40 minutes ago Member since: May 9, 2000
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  • I am attempting to understand the reason afrezzauser was able to get his a1c into the 6s during his Afrezza trial period. On August 13 I thought I understood what happened, but afrezzauser on August 18 replied I was incorrect. On August 20 I replied to ask what the reason was that he was able to get his a1c into the 6s, and I offered some guesses. So far I have not received a reply, but perhaps someone who posts here knows the answer.

    On August 13 dontdropyourlunch wrote:
    antimatter0007, I am sure you can get more valid information and color on the issue from afrezzauser. I suppose he is only doing facebook, because I don't see him posting on Yahoo anymore. Afrezzauser wrote about wanting his doctor during the trials to increase his basal dose for a lower A1C steady state while afrezzauser was using Afrezza, but his doctor apparently was concerned about such a low end A1C relative to what the doctor was accustomed to. The doctor just did not know how well the combination of the basal and the Afrezza would work. I am sure afrezzauser can give us the straight story.

    On August 18 afrezzauser replied:
    This is not correct. My doctor lowered my basal and lowered my bolus which in this case would be afrezza. He lowered my afrezza dose when my a1c went into the 6s. He lowered my basal long before that. My a1c dropping to the 6s had nothing to do with my basal dose as that was steady the last 4 months and he dropped it from the initial run in.

    On August 20 I dontdropyourlunch replied:
    afrezzauser, could you explain the reason or mechanism that was able to lower your a1c into the 6s (from the 7s or higher I presume). I will offer some guesses just to let you know I have put some thought into my curiosity. Was it a change in basal insulin brand? Was it more exercise? Was it a diet change? Was it the stabilization from the Afrezza bolus that inhibited the high excursions in blood sugar? If not any of these, could you give the reason/mechanism.

  • dontdropyourlunch dontdropyourlunch 22 hours ago Flag

    dmorgan2151, do you mean frigid due to excess cloud cover or excess smoke and ash in the upper atmosphere?

  • dontdropyourlunch dontdropyourlunch 22 hours ago Flag

    afrezzauser, could you explain the reason or mechanism that was able to lower your a1c into the 6s (from the 7s or higher I presume). I will offer some guesses just to let you know I have put some thought into my curiosity. Was it a change in basal insulin brand? Was it more exercise? Was it a diet change? Was it the stabilization from the Afrezza bolus that inhibited the high excursions in blood sugar? If not any of these, could you give the reason/mechanism.

  • dontdropyourlunch dontdropyourlunch Aug 16, 2014 7:51 PM Flag

    trade_pro101, I had not noticed the Fibonacci 50% retracement, and you are right. On my stockchart it shows 6.55 as the exact level for 50%, but we know how subjective this is rolled into psychology and all that. Also the RSI and STO oscillators are very oversold too.

  • Reply to

    lantus plus afrezza premix inhalation

    by brheavy Aug 15, 2014 6:48 AM
    dontdropyourlunch dontdropyourlunch Aug 15, 2014 1:48 PM Flag

    michaelmurphy234, I am interested in a GLP-1's action. I don't think I understand the needs of a type 2 to be prescribed a GLP-1. I am under the impression type 2s that are insulin resistant or whose pancreas does not secrete enough insulin are candidates for a GLP-1. However it seems to me Afrezza could provide the extra concentration of insulin needed both to mop up the blood sugar by the resistant cells as well as not to make the "defective" pancreas beta cells work any harder than they currently do. It seems using Afrezza could avoid the long term impact of possibly causing the pancreas to fail due to overwork producing insulin it would not have produced had the GLP-1 not been used. Also the side effects of GLP-1s sound uncomfortable to scary mentally for type 2s who use a GLP-1. I did not know GLP-1s need to be mixed. What has to be mixed? Thanks for any light you can shed on my questions or statements.

  • Reply to

    lantus plus afrezza premix inhalation

    by brheavy Aug 15, 2014 6:48 AM
    dontdropyourlunch dontdropyourlunch Aug 15, 2014 1:28 PM Flag

    brheavy, I don't know what covenants or restrictive covenants exist in the contract between Sanofi and Mannkind, but from documents I have read from Mannkind's SEC filings, I did not find anything that prohibits MNKD from working with any other company on anything else, including a long acting insulin like Novo's. Sanofi does have explicit right of first negotiation for a GLP-1, but I found nothing about rights for anything else. Even if Sanofi has right of first negotiation for a GLP-1, that does not mean some other company could offer more or a better deal to MNKD that MNKD could accept.

  • dontdropyourlunch dontdropyourlunch Aug 15, 2014 11:09 AM Flag

    jhnnylikes, near the end of the 10-Q you will find Sanofi only has rights to Negotiate the first GLP-1. No guarantee a deal with Sanofi would be the first if a better deal for a GLP-1 came in to MNKD.

  • Reply to

    From a Prominent Poster On this Board :

    by crs2919 Aug 14, 2014 3:01 PM
    dontdropyourlunch dontdropyourlunch Aug 14, 2014 4:34 PM Flag

    crs2919, I am not going to pass judgment on "the process" information you have, but the insulin that is frozen in Danbury would be called "in process" insulin if it is truly going to be qualified as Afrezza by Sanofi for FDA approval. I accept that Sanofi could have rights to the "in process" insulin, but I don't understand why Sanofi would want to recreate Pfizer's insulin making process. Sanofi makes human recombinant insulin itself already. Help me understand.

  • dontdropyourlunch dontdropyourlunch Aug 14, 2014 2:22 PM Flag

    sugarman005, let's see, the harpsichord was used until the piano was invented, and composers found it much better than the harpsichord in their works. There was wide skepticism about the iPad making any inroads at all, much less quickly, in the PC market. When a new tool with new technology that works differently, offers a new concept and new choices for consumers, and offers something not possible with previous tools, then literature and guidelines change if people want it.

    Just because you, a market of one person, feel doctors and nurses won't change in their prescribing for type 2 diabetics, I think Sanofi will be out to change that mindset through education and some testing of their own that can demonstrate results. They will help the AACE/ADA modify the guidelines. We already know the ADA top people support Afrezza due to their very positive presentations at the MNKD AdCom on April 1st.

    If I were a type 2 diabetic needing prandial insulin, and I heard from other diabetics or TV about Afrezza, and you were telling me, as a caregiver of some type, that you won't prescribe it for me, I would be leaving your office for another doctor/caregiver who would let me try it.

    It appears to me that you believe doctors and the medical community have their neurons frozen when it comes to something that might be better for patient compliance and/or better than prescribing a rapid acting insulin or a GLP-1. Sanofi will be out to change that, because I think Sanofi believes they have a new weapon to control and hold the range of blood sugar excursions when Afrezza is used as the prandial (meal time) insulin.

  • I lifted this from Adam F's latest. The all capitalized three words (I did the all caps in 3rd paragraph) is a certain patient subgroup that must eat food several times each day. Quite a subgroup, and quite an understatement by this JP Morgan analyst don't you think. Seems an absurd comment by the analyst calculated to interest the ignorant in the financial community. Also this meme of "lower relative efficacy" was thoroughly debunked in the ADCOM meeting with the expert panel on April 1, 2014. If one is a type 1 or type 2 diabetic and you have to eat food (100% of diabetics), Afrezza is for you each meal time. Adam needs to have a sit down conversation with a Sanofi diabetes educator to set him straight on some simple facts about Afrezza -- assuming Adam wants some facts about Afrezza. I feel sure before Afrezza is introduced into the diabetes drug market, Cramer will have someone from Sanofi on his program to explain why Sanofi selected Afrezza and what advantages Sanofi thinks it will have in the diabetes market.

    "J.P. Morgan analyst Cory Kasimov believes MannKind did well landing Sanofi as the Afrezza partner. He called the deal a positive for MannKind. But... "

    "However, even with SNY, we remain skeptical that the commercial potential of Afrezza is enough to warrant its current valuation, especially considering the perceived lower relative efficacy vs. injected insulin, potential limitation of use to CERTAIN PATIENT SUBGROUPS, and lingering safety concerns. Indeed, we estimate that Afrezza has to match the leading mealtime insulin in the world just to justify MNKD’s current valuation let alone offer upside potential. [Emphasis his.]"

  • dontdropyourlunch dontdropyourlunch Aug 13, 2014 1:03 PM Flag

    antimatter0007, I am sure you can get more valid information and color on the issue from afrezzauser. I suppose he is only doing facebook, because I don't see him posting on Yahoo anymore. Afrezzauser wrote about wanting his doctor during the trials to increase his basal dose for a lower A1C steady state while afrezzauser was using Afrezza, but his doctor apparently was concerned about such a low end A1C relative to what the doctor was accustomed to. The doctor just did not know how well the combination of the basal and the Afrezza would work. I am sure afrezzauser can give us the straight story.

  • dontdropyourlunch dontdropyourlunch Aug 13, 2014 2:39 AM Flag

    antimatter0007, you can be sure Sanofi already has had the private trials going on with Lantus/Afrezza to show insurance companies what can be achieved while titrating to a lower A1C level using basal Lantus along with Afrezza at meal times to prove the range of blood sugar excursions stay in range without hyperglycemia and especially without hypoglycemic events. In addition such private trial information that Sanofi obtains can and will be used to improve the FDA label for Afrezza.

  • dontdropyourlunch dontdropyourlunch Aug 13, 2014 2:28 AM Flag

    rmerritt33, I don't understand why you would not use Afrezza each time you eat a meal. Why only 5 times per week in your thought options? The blood sugar excursions happen anytime you eat something unless your pancreas sort of works intermittently.

  • Reply to

    Full disclosure - I sold half my shares

    by radgray68 Aug 12, 2014 11:47 AM
    dontdropyourlunch dontdropyourlunch Aug 12, 2014 2:24 PM Flag

    factspls88, I don't know anything about the Regeneron partnership with Sanofi. Is it a distribution agreement similar to MNKD's? Did Sanofi buy part of Regeneron equity?

  • Reply to

    Is the Sanofi Partnership Exclusive?

    by poondizzy Aug 12, 2014 2:17 PM
    dontdropyourlunch dontdropyourlunch Aug 12, 2014 2:20 PM Flag

    poondizzy, exclusive just for Afrezza. Are you able to read the press release as well as SEC filings?

  • Reply to

    Houston, we have liftoff...

    by antimatter0007 Aug 12, 2014 1:56 AM
    dontdropyourlunch dontdropyourlunch Aug 12, 2014 2:34 AM Flag

    opc11, you are incorrect. I posted the change of control language used in the agreement. They have no right of refusal for a buyout of the company.

  • dontdropyourlunch by dontdropyourlunch Aug 12, 2014 1:42 AM Flag

    Should MNKD receive a buyout offer, or should MNKD solicit a buyout offer from a buyer, Sanofi does not have any right of first refusal. In the 10-Q from 8/11/14 this is the relevant language that applies. "In addition, if our board of directors determines to pursue a change of control of MannKind, we will be required [to] notify Sanofi of such determination within a certain period of time so that Sanofi may, at is discretion, negotiate with us for a potential acquisition of MannKind by Sanofi." All that means is that Sanofi will have a chance to negotiate an offer should another offer be on the table or contemplated. It will be open season.

  • dontdropyourlunch dontdropyourlunch Aug 12, 2014 1:34 AM Flag

    charles_lacy2003, this is absolutely not true. Sanofi does not have any right of first refusal on any buyout offer for MNKD. I located the pertinent language in the 10-Q, and I will paste the relevant language in a separate post titled Change of Control. MNKD is only required to notify Sanofi of a contemplated change of control so that Sanofi, at its discretion, may negotiate for a potential acquisition of MNKD. There is nothing so onerous as a right of first refusal in the deal language.

  • dontdropyourlunch dontdropyourlunch Aug 12, 2014 12:31 AM Flag

    kevinmik, yes, I guessed right. I just read from the patent you posted. Directly in the 1st summary paragraph below the claims, it states, "Powders made with the present microparticles can deliver increased drug content in lesser amounts of powder dose, which can facilitate drug delivery to a patient." The new process allows more insulin concentration, in Afrezza's case, to be adsorbed on the Technosphere powder. So a patient would be able to inhale less powder for a given dose of insulin, and it would save MNKD money because it would use less chemicals per Afrezza cartridge.

  • dontdropyourlunch dontdropyourlunch Aug 12, 2014 12:07 AM Flag

    kevinmik, I posted a comment about this patent in another thread in which you posted this same patent information.

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