|
|
Post by sportsrancho on Dec 26, 2022 18:55:59 GMT -5
That could certainly be interesting. Hopefully the NDAs had an expiration time frame. Even if Sam can't disclose details of the meeting it would still be interesting to hear his and Eric's current perspective on Afrezza. I wonder if that's the reason why they have CLAMMED UP. They were the 2 most outspoken people on Afrezza. Wonder if they were on SNY's Social Media payroll? No. And they have not clammed up, Sam is very active on the private Afrezza Facebook page. I think I posted a Twitter post from Eric a while back. Sam just doesn’t do Twitter anymore he’s busy on Instagram. He got a new place in Florida and he’s all excited about fixing it up. They are both still on Afrezza, and use nothing but it and basal. |
|
|
|
Post by prcgorman2 on Dec 27, 2022 14:24:38 GMT -5
I wonder if that's the reason why they have CLAMMED UP. They were the 2 most outspoken people on Afrezza. Wonder if they were on SNY's Social Media payroll? No. And they have not clammed up, Sam is very active on the private Afrezza Facebook page. I think I posted a Twitter post from Eric a while back. Sam just doesn’t do Twitter anymore he’s busy on Instagram. He got a new place in Florida and he’s all excited about fixing it up. They are both still on Afrezza, and use nothing but it and basal. I read a lot of Sam's commentary back in 2014 and 2015. He made it obvious how "life changing" Afrezza has been for his management of his Type 1 diabetes. Glad to hear he is still active and doing well. One of the things I worry about is Afrezza being shelved as a product because of stories like Sam's. His hypoglycemia experiences prior to being able to use Afrezza were a nightmare. Thank you for sharing sports! |
|
|
|
Post by sportsrancho on Jan 5, 2023 1:30:17 GMT -5
|
|
|
|
Post by uvula on Jan 5, 2023 13:29:31 GMT -5
Eric looks younger than I remember. Must be due to Afrezza.
|
|
|
|
Post by mango on Jan 11, 2023 12:35:47 GMT -5
The SoC is a failure. People with diabetes aren’t getting better, they’re getting worse. First line treatments for T2Ds and basal recommendations are all medically incorrect, the antiglycemics have horrific safety profiles, and are inferior to the inhaled insulin, Afrezza. The mealtime insulin recommendations in the SoC for both T1D and T2D favor the RAAs—a barbaric recommendation based primarily on HbA1c data, which itself is an antiquated metric and does not accurately assess glucose homeostasis but favors the RAA profile (significantly increased hypoglycemic events which lead to dramatic reduction in HbA1c, which gives a misleading representation of performance and overall condition).
A1C has been known as the gold standard, but it does not provide information about hypoglycemia, hyperglycemia, or daily fluctuations in glucose levels. Time in range, however, gives all this data and more. It’s the most accurate measurement of glucose homeostasis to date.
To quote MannKind,
“In analyzing HbA1c results, it is important to remember that HbA1c is essentially a proxy for average blood glucose levels. Fasting levels can affect this, but so can many other things. As an example, frequent plunges in blood glucose levels, including those resulting in hypoglycemia, from any excess insulin remaining in the bloodstream following meal digestion, can have a dramatic effect on HbA1c. It would be hard to argue that this late plunge of glucose is a good thing, yet it does lower HbA1c levels. As such, HbA1c is an imperfect measure of the beneficial effect of a prandial insulin. However, this is the accepted measure of efficacy used today by the FDA.
As has been consistently shown in earlier trials we have shown in both these Affinity studies that Afrezza reduces both the prandial rise in blood sugar following a meal and also reduces the frequency and degree of hypoglycemia, smoothing out the curves, so to speak. But this does not necessarily result in better HbA1c results, which is why the Affinity 1 trial was designed to be a non-inferiority trial, not a superiority trial. Our primary objective with Affinity 1 was to produce data that would support approval of this product and get it on the market. We expect that in real like use the inherent advantages of Afrezza over other prandial insulins and also non-insulin anti-glycemic agents will quickly become apparent, making it a commercial success.“
Evidence shows that consistently good TIR will alter the HbA1c down to the natural healthy level on its own with Afrezza, without the help of increased and significant frequency of hypoglycemic events like that seen with RAAs.
|
|
|
|
Post by uvula on Jan 11, 2023 13:54:25 GMT -5
"We expect that in real like [sic] use the inherent advantages of Afrezza over other prandial insulins and also non-insulin anti-glycemic agents will quickly become apparent, making it a commercial success.“
Did he say this recently?
|
|
|
|
Post by mango on Jan 11, 2023 14:15:00 GMT -5
|
|
|
|
Post by cretin11 on Jan 11, 2023 14:45:28 GMT -5
"We expect that in real like [sic] use the inherent advantages of Afrezza over other prandial insulins and also non-insulin anti-glycemic agents will quickly become apparent, making it a commercial success.“ Did he say this recently? It’s all relative. Compared with the invention of fire, it was a recent statement. Unfortunately enough time has passed that the statement can be declared incorrect (though not from any fault of the product itself). |
|
|
|
Post by uvula on Jan 11, 2023 14:50:07 GMT -5
That quote is almost 10 years old and no real progress in the SOC since then. Almost embarrassing at this point. |
|
|
|
Post by prcgorman2 on Jan 11, 2023 16:35:26 GMT -5
That quote is almost 10 years old and no real progress in the SOC since then. Almost embarrassing at this point. Not almost. Embarrassing. Especially if you are Dr. David Kendall, even if it isn't his fault he wasn't able to usefully "move the needle" (pun intended).
If the statement had said the same thing but instead of "quickly" had said "...over an extended period of time such as a decade or more...", than it could still be true.
|
|
|
|
Post by mango on Jan 11, 2023 16:35:45 GMT -5
What’s embarrassing is the lack of advocacy and awareness ADA gives the world’s only inhaled insulin, and world’s only mealtime insulin that mimics physiologic insulin.
|
|
|
|
Post by sayhey24 on Jan 11, 2023 18:53:17 GMT -5
What’s embarrassing is the lack of advocacy and awareness ADA gives the world’s only inhaled insulin, and world’s only mealtime insulin that mimics physiologic insulin. Is it the ADA or Mike? This one I squarely place on Mike. Has he done the spade work required? Has he lined up a bulldozer which will be required to move the ADA? Mikes been around for 7 years and what T2 afrezza studies have been done? Have we had any afrezza/GLP1 studies? I bet adding afrezza to Mounjaro significantly improves post prandial glucose control but we don't know because we never even did a pilot study. At least Kendall started doing some T1 studies before he disappeared prior to his former employee announcing P3 study results for Mounjaro. |
|
|
|
Post by peppy on Jan 11, 2023 19:39:18 GMT -5
What’s embarrassing is the lack of advocacy and awareness ADA gives the world’s only inhaled insulin, and world’s only mealtime insulin that mimics physiologic insulin. Is it the ADA or Mike? This one I squarely place on Mike. Has he done the spade work required? Has he lined up a bulldozer which will be required to move the ADA? Mikes been around for 7 years and what T2 afrezza studies have been done? Have we had any afrezza/GLP1 studies? I bet adding afrezza to Mounjaro significantly improves post prandial glucose control but we don't know because we never even did a pilot study. At least Kendall started doing some T1 studies before he disappeared prior to his former employee announcing P3 study results for Mounjaro. When I look at the biotechnology and big Pharma names that have high share holder price, it is big Pharma. MRK, LLY, GILD, AMGN, REGN, JNJ, now MRNA. Big Money and large balance sheets set up the trials and the Standards of care. Every trial we do goes against an Rapid Acting Insulin with the HGB A1c as the Outcome determinate. Also the protocols is always using Afrezza the same way RAA are supposed to be used, prior to a meal. Mango is correct, the hypos from the RAA's are leveling out the highs. The only way to compete with the subq RAA's are to second dose Afrezza. The only way to know that is a CGM. Money talks. I know you believe there is a correct medical way to treat type 2 diabetes. I don't think established system cares. I think it is about money. |
|
|
|
Post by mango on Jan 12, 2023 8:38:48 GMT -5
Blaming Mike is disingenuous. Fact is, Afrezza was rushed to get approved and we are paying the price for that today. Botched clinical trials (taking COPDers off their meds are you serious?), only non-inferior clinical trials, didn’t even have the dosing correct in any clinical trial, failure to conduct a pediatric clinical trial. I could go on. Mike is the one that got Peds going and that’s going to readout Q4 this year. Mike is the one that got Afrezza in Bazil and soon India (that’s going to readout this year as well). Mike is the one who has done multiple Phase 4 clinical trials. Mike is the one who has acknowledged that dosing was never figured out in the first place.
It’s the ADA’s job to advocate for people with diabetes. We have the world’s only inhaled insulin and it mimics what’s in the body. Complete crickets from ADA.
Why? Money. There’s a vested interested in the SoC by Big Pharma and they all are rewarded handsomely from it (including ADA). Let’s not kid ourselves, this has more to do with paying to play than anything else. It’s a damn shame ADA never mentions Afrezza. It’s truly unbelievable and a great case study of where medical establishment’s and gatekeeper’s intentions are at.
|
|
|
|
Post by prcgorman2 on Jan 12, 2023 9:38:57 GMT -5
Blaming Mike is disingenuous. Fact is, Afrezza was rushed to get approved and we are paying the price for that today. Botched clinical trials (taking COPDers off their meds are you serious?), only non-inferior clinical trials, didn’t even have the dosing correct in any clinical trial, failure to conduct a pediatric clinical trial. I could go on. Mike is the one that got Peds going and that’s going to readout Q4 this year. Mike is the one that got Afrezza in Bazil and soon India (that’s going to readout this year as well). Mike is the one who has done multiple Phase 4 clinical trials. Mike is the one who has acknowledged that dosing was never figured out in the first place. It’s the ADA’s job to advocate for people with diabetes. We have the world’s only inhaled insulin and it mimics what’s in the body. Complete crickets from ADA. Why? Money. There’s a vested interested in the SoC by Big Pharma and they all are rewarded handsomely from it (including ADA). Let’s not kid ourselves, this has more to do with paying to play than anything else. It’s a damn shame ADA never mentions Afrezza. It’s truly unbelievable and a great case study of where medical establishment’s and gatekeeper’s intentions are at. Big pharma are the sponsors of the ADA and therefore have undeniable influence. We used to see posts on PB which said how MNKD stock was manipulated in an effort to kill MNKD and Afrezza because BP was "scared". There may have been truth to those assumptions, but I doubt we'll ever know. I assume BP doesn't give a hoot about MNKD or Afrezza because they don't have to. MNKD and Afrezza are not an imminent threat to their cash cows. Prescribers and insurance providers are both reluctant and without those two things, scripts will be low and stay that way indefinitely (but perhaps not permanently).
Great leaders adapt and overcome challenges and obstacles. Nobody can take away from Mike Castagna that he created a sales and marketing team out of thin air and "relaunched" Afrezza with a shoestring budget, managed carefully, and narrowly avoided bankruptcy which was the path Mannkind was on. He is owed a debt of gratitude. The question on the table is now that he's successfully managed the company to the brink of profitability (which may be very profitable) on the Tyvaso DPI accomplishment, can he take things to the next level and beyond? Time will tell of course, but sayhey's constant stream of observations and suggestions are persuasive and I am eager for Mike to take on some more risk with targeted efforts to improve the Afrezza story.
|
|
