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Post by ezrasfund on Mar 2, 2015 12:55:18 GMT -5
I think Afrezzauser said that they were not permitted to use a CGM during the trials. Remember everyone in all arms of the study must follow the exact same protocol. So either everyone is using a CGM or no one is.
You are right about the FDA disputing the data. It seems that the problem was mostly with statisticians and not endocrinologists.
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Post by cybergym66 on Mar 2, 2015 13:12:28 GMT -5
I think Afrezzauser said that they were not permitted to use a CGM during the trials. Remember everyone in all arms of the study must follow the exact same protocol. So either everyone is using a CGM or no one is. You are right about the FDA disputing the data. It seems that the problem was mostly with statisticians and not endocrinologists. Was it they didn't have CGMs or the visual output was disabled so patients couldn't see the data? |
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Post by mannmade on Mar 2, 2015 13:19:59 GMT -5
Honestly, I think the trials are past history as they were clearly designed to creates the lowest threshold for success in getting Afrezza approved and avoiding a 3rd crl which would have been the death of Afrezza.
Having accomplished this short term goal, it is ironic that the successful completion of the last Phase 3 studies has created a longer term issue for the marketing of the product which the new studies should fix but will likely take 2 years or so to do so.
Here's one irony, the inclusion on the label that use of Afrezza may cause hypo's. Duh... it's insulin. What is not being and cannot be said by Sanofi is that the likelihood of sever hypos is greatly reduced so the impression left for anyone who has not done their DD is that it is no better and may be worse than current therapies.
Thank g-d for Sam and others like him as they can say what Sanofi can't. So with sam's latest experiment we find out that what Al has said all along is true... Significantly less hypos...
The FDA was not our friend on this but now it is also in the rear view mirror and moving forward I think the education process and subsequent adoption will validate the longs...
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Post by brentie on Mar 2, 2015 13:36:26 GMT -5
FDA's refusal to factor in Afrezza's speed is what led to poor trial protocols. It's as if FDA officials wanted it to fail.
Another subject I've been wondering and keep forgetting to ask regarding the trials - maybe some of you know the answers to some of these questions:
Sam said he used a CGM during the trials. Did all trial participants get a CGM? If that were the case, they had the potential to record an incredible amount of information. Were the only data points recorded those that the FDA deemed worthy? Were the rest of the measurements collected by CGM's thrown out or not collected at all? It seems that Sam is trying to prove to the world something he discovered about Afrezza during the trials.
Wasn't the trial physician (Dr. Edelman or something like that?) recently was quoted as saying that the FDA spent so much time disputing the data that they missed its importance? From AU in "Why is Afrezza better now than on the Trials?" "The first thing that comes to mind for me is that the trial #’s never told the whole story. This is so evident now that I can visually see how verifiably Afrezza mimics the human pancreas. In the drug trials we all wore a CGM (continuous glucose monitor) for a week or so, but we could never see what the numbers were or how we were doing (ie. because the output of the device was completely disabled from being viewed). As many of you who follow me on twitter know, I am always “in zone” over 85% of the time now without much effort, because of practice/experience using Afrezza along with the knowledge of how the doses will affect my body (ie. how much my BG will drop when I use Afrezza and for how long)." afrezzauser.com/blog/ |
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Post by babaoriley on Mar 2, 2015 14:10:45 GMT -5
I was thinking proctology. Oh, Liane and Spiro, you are both so wrong! And I'm surprised Liane fingered me as a proctologist (can't imagine what triggered that, perhaps mannmade or one of the nurses told her of my personalized license plate "assman" - had to hustle to get that in California after the Seinfeld episode!) Liane, I give people the needle, to be sure, but the finger?? "Psychiatrist, with sub-specialty in over-active stock message boards" would be my way in to the Medical Letter. I have a complete dossier and psychological profile on each of you with over 200 posts. Put it this way, if many of us end up in NY/Danbury for the meeting, I would suggest staying together in groups of at least 5 or 6. |
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Post by babaoriley on Mar 2, 2015 14:13:38 GMT -5
www.thestreet.com/story/13062927/1/mannkinds-afrezza-earns-lackluster-review-from-independent-drug-arbiter.html?puc=stocktwits&cm_ven=STOCKTWITS&utm_source=dlvr.it&utm_medium=organic&utm_campaign=stocktwits MannKind's Afrezza Earns Lackluster Review from Independent Drug Arbiter ADAM FEUERSTEIN Follow Mar 2, 2015 8:15 AM EST Afrezza is "modestly effective" at reducing blood glucose and its long-term safety is unknown, according to a review of the inhaled insulin published this week by The Medical Letter, an independent, non-profit organization which evaluates prescription drugs. MannKind (MNKD) developed Afrezza and secured U.S. approval last June. The rapid-acting inhaled insulin, intended for use during mealtime by Type 1 and Type 2 diabetics, was launched commercially one month ago by MannKind's marketing partner Sanofi (SNY). The Medical Letter is influential with doctors and other healthcare professionals because the organization doesn't accept industry money and publishes drug information that aims to be an "unbiased consensus of scientific experts." The two-page review of Afrezza in the March 2 issue of The Medical Letter, available only to subscribers, describes the efficacy and safety data from the clinical trials included in the product's FDA-approved label and places Afrezza in the context of other rapid-acting mealtime insulins, all of which require injections. The review concludes: "Afrezza, the only inhaled formulation of insulin currently available in the US, appears to be only modestly effective in reducing HBA1c. Cough is a common side effect and the long-term pulmonary safety of inhaling insulin is unknown." The Medical Letter's review also includes a pricing chart showing Afrezza to be more expensive than the competing injectable insulins marketed by Novo Nordisk (NVO) (Novolog), Eli Lilly (LLY) (Humalog) and Sanofi (Apidra.) Doctors have written 290 prescriptions for Afrezza during the first four weeks of the launch, according to Symphony Health. Love the way the market has responded to Adam's trash! Remember the scene at the end of Damn Yankees with Ray Walston (playing the devil) jumping up and down cuz he's been foiled? Can't you just picture that peach of a human being AF doing just that? |
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Post by mannmade on Mar 2, 2015 14:49:15 GMT -5
Baba, one of my all time favorite movies as a kid... And I am not a Yankee fan... I also remember "whatever Lola wants, Lola gets..." Btw, this may explain the frequency of the share price stopping on $6.66 so much as it is now as I am typing this... weird! Perhaps AF really is the devil or as the say the devil is in the details and he chooses to ignore such... Oh well now I am just rambling...
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Post by ezrasfund on Mar 2, 2015 14:58:17 GMT -5
Unfortunately AF's headline with "lackluster review" gets re-posted and re-tweeted over and over. It just appeared 4 more times on #afrezza.
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Post by liane on Mar 2, 2015 15:18:53 GMT -5
Unfortunately AF's headline with "lackluster review" gets re-posted and re-tweeted over and over. It just appeared 4 more times on #afrezza. That's exactly the problem |
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Post by BD on Mar 2, 2015 15:25:59 GMT -5
Well, yeah, and then everyone immediately comes here and reads the comments, realizes AF is FOS, and buys the dip. I can live with a pattern like that...
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Post by gomnkd on Mar 2, 2015 15:26:41 GMT -5
AF needs to meet his daily quota of page views. He has a dog, wife and kids to feed. What better way than to post something on Afrezza?
Come to think of it, Pissco-analyst (that's what my dad calls them) has also made this a source of income. Hope he buys a share or two of MNKD.
Like flies getting attracted to a pile of dung, MNKD followers simply can't resist it.
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Post by dreamboatcruise on Mar 2, 2015 17:09:55 GMT -5
2 pens = 600 units of Insulin Afrezza = 600 units of Insulin So they did a complete BS comparison with equal insulin units but failed to account for zero loss due to priming. So shady. Comparison would be hard for anyone to do as data about how many units are used on average each time is probably not readily available. If you're comparing units to units, Afrezza would have a compensating "loss" because of coming in 4 and 8u cartridges. Some might need to bolus with 1 or 5 with the injectable, and assuming 2u of priming they've only used 3 or 7u with pen but need 4 or 8 with Afrezza. If one assumed uniform distribution of the actual required dose, it would seem Afrezza comes out ahead, with a pen requiring 12.5% more units, but that's not a huge difference. I assume that Sanofi has been smart enough to maximize profit on Afrezza while being on the path to get formulary placement equivalent to pens. If we make a little more profit than a pen, good. |
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Post by babaoriley on Mar 2, 2015 17:18:41 GMT -5
dbc, I have to trust Sanofi going into the deal that they knew the pricing could be competitive, otherwise, they would not do very well. Since we have incomplete info, I just rely on SNY's calculations (and MNKD's for that matter). We're fine on pricing, of that, I'm pretty confident, without putting a pen to paper (don't use those calculator things, that's cheating!).
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