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Post by cretin11 on Dec 16, 2015 10:19:46 GMT -5
Nice find. Seems like it wouldn't be a total conflict, since Afrezza isn't being touted as a cure (although there is evidence that early use could stave off the disease). His interview is definitely a head scratcher though, I'm also wondering what his bias is, if any.
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Post by dreamboatcruise on Dec 16, 2015 16:39:14 GMT -5
Dr Jeremy Pettus: Potential conflict of interest? I don't generally post, but am a staunch MNKD long and Proboards reader. I stumbled on this info from a ST poster, also a long, who has been reliable (opsguy). The following link and story somewhat clarifies Dr. Pettus' confusing stance on Afrezza -- he is working on a stem cell cure for diabetes at UC........also makes one wonder why Hoskins chose him to interview.....on the other hand, even a competitor couldn't deny the outstanding feedback from the early adopters. (hope the link works....don't really know how to do this!) www.wfmz.com/lifestyle/Health-Beat/Health-Beat-Stem-cells-for-diabetes/34253436 Stem cell cure is a LONG ways off. Not only that but would be terribly expensive initially. Prandial insulins likely have a role for a long time to come. So I can't imagine he would be biased against Afrezza because of that. |
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Post by sluggobear on Dec 16, 2015 18:04:17 GMT -5
I have not seen definitive proof that Sanofi sponsored the Afrezza meeting for the 12 Afrezza users. Can anyone confirm that Edelman, Sam Finta, Jeremy Pettus (or anyone credible) mentioned that it was a Sanofi-sanctioned event. Confirmation that Sanofi was interested in real life Afrezza use to design a clinical trial would be very important for my very low self-esteem right now.
Thanks.
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Post by dreamboatcruise on Dec 16, 2015 18:47:49 GMT -5
I have not seen definitive proof that Sanofi sponsored the Afrezza meeting for the 12 Afrezza users. Can anyone confirm that Edelman, Sam Finta, Jeremy Pettus (or anyone credible) mentioned that it was a Sanofi-sanctioned event. Confirmation that Sanofi was interested in real life Afrezza use to design a clinical trial would be very important for my very low self-esteem right now. Thanks. The blogger mentioned that the purpose was to design trials. People we know said they had knowledge of this meeting in response to posts about SNY having a meeting. So looks pretty certain it was SNY. |
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Post by sluggobear on Dec 16, 2015 19:35:11 GMT -5
Thanks. I just haven't seen it stated explicitly. Of course, I want to assume that Sanofi sponsored the travel and meeting; just being careful of my assumptions. But I'd be surprised if Edelman or the TCOYD group had covered expenses.
It makes good sense that Sanofi is taking this approach to design better trials. I doubt they would get half the key information regarding basic user experiences from the Afrezza prescribers (unless they were Edelman and took Afrezza also).
I don't like to waste a lot of time speculating unless it might actually be productive. I will search the board for previous threads that possibly considered clinical trial design for better labeling.
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Post by rvc on Dec 16, 2015 19:38:48 GMT -5
I believe the person on YMB that first 'broke' this story wrote that SNY was paying for the early adopters expenses though a 'front company', which seems rather fishy to me. The guy was right on every other detail though, so who knows. At any rate, it is merely conjecture that SNY had anything to to with the presentation, and given their feeble marketing Afrezza so far, I would guess not.
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Post by dudley on Dec 16, 2015 19:39:10 GMT -5
It makes all the sense in the world that Sanofi WOULD want to do a trial to demonstrate clear superiority. They have to know by now the true capability of Afrezza but due to current label restrictions they cannot advertise it as such or make ANY claims to that superiority. Why would they want to spend huge amounts of money now on advertising something that they cannot differentiate as a true game changer? A label change allows all the clear benefits to be highlighted. It's equivalent to spending a ton of advertising for a Maserati but you have to restrict yourself to only Chevrolet terminology. Getting a clear label change now opens the doors to devastating advertising, gives doctors a clear and compelling reason to prescribe, and undoubtedly assures future country approvals more expeditiously. Current labeling unfortunately limits Afrezza as just another prandial insulin that happens to be inhaled vs. injected. Many doctors and patients view it that way as well since there is no OFFICIAL version of everything the early adopters are experiencing.
I for one would much rather see them spending money for a superiority trial than for watered-down advertising that is not going really going to move the needle. Long term that is much greater bang for the buck. I also believe this is a powerful reason we have not seen more marketing effort thrown at the situation as it currently exists. A six month trial would be sufficient to document ALL the things we know are possible: Quicker in and out, greatly simplified carb counting, easy corrections, lower hypos, lower HbA1c's, - all leading to improved quality of life and lesser future complications. HUGE benefits over all existing competition. THAT opens the door to huge growth, much more favorable insurance coverage as a superior treatment that saves insurance companies money over the patient life. Much more effective than spending a ton of money on me-too advertising.
Gotta believe SNY sees this - no surprise at all to me if we hear about just such a trial this year.
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Post by suebeeee1 on Dec 16, 2015 21:42:55 GMT -5
Unfortunately, it is a catch 22. If Sanofi only begins the trials now in order to show superiority and get a label change, those trials could take two years...or more! During that time, they don't lower the price which will keep insurance companies from adding Afrezza to their formularies. Additionally, Sanofi doesn't advertise because they don't want to waste money until the label is changed and the insurance companies cover and pay more.
Can MNKD survive more than a year without significant changes in sales?
The trials are important, but the insurance and advertising is more so.
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Post by dreamboatcruise on Dec 16, 2015 22:14:27 GMT -5
Unfortunately, it is a catch 22. If Sanofi only begins the trials now in order to show superiority and get a label change, those trials could take two years...or more! During that time, they don't lower the price which will keep insurance companies from adding Afrezza to their formularies. Additionally, Sanofi doesn't advertise because they don't want to waste money until the label is changed and the insurance companies cover and pay more. Can MNKD survive more than a year without significant changes in sales? The trials are important, but the insurance and advertising is more so. Sorry if I'm sounding broken record to some, but I disagree on the need for such long studies. It comes with the caveat that I'm not a medical researcher, but to me it would seem that a study anywhere from 3-6 months would be sufficient to show better control of blood glucose. This is assuming the medical community accepts the concept that lower A1c is a good thing. Obviously if you had to show some other end point such as lower cardiovascular risk, less neuropathy development, etc. you are talking about very long, expensive study. But I would think lower spikes and/or lower A1c without increasing risk of serious hypos would suffice. In another thread I discussed a study being done to look at useful of CGMs in real time dosing... and one of the research directors states that at least one person using Afrezza. This study only has each patient participate for 3 months. Don't see why Afrezza study would need to be longer if it were also based on CGM. mnkd.proboards.com/post/52801 |
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Post by compound26 on Dec 16, 2015 22:29:04 GMT -5
Unfortunately, it is a catch 22. If Sanofi only begins the trials now in order to show superiority and get a label change, those trials could take two years...or more! During that time, they don't lower the price which will keep insurance companies from adding Afrezza to their formularies. Additionally, Sanofi doesn't advertise because they don't want to waste money until the label is changed and the insurance companies cover and pay more. Can MNKD survive more than a year without significant changes in sales? The trials are important, but the insurance and advertising is more so. Sorry if I'm sounding broken record to some, but I disagree on the need for such long studies. It comes with the caveat that I'm not a medical researcher, but to me it would seem that a study anywhere from 3-6 months would be sufficient to show better control of blood glucose. This is assuming the medical community accepts the concept that lower A1c is a good thing. Obviously if you had to show some other end point such as lower cardiovascular risk, less neuropathy development, etc. you are talking about very long, expensive study. But I would think lower spikes and/or lower A1c without increasing risk of serious hypos would suffice. In another thread I discussed a study being done to look at useful of CGMs in real time dosing... and one of the research directors states that at least one person using Afrezza. This study only has each patient participate for 3 months. Don't see why Afrezza study would need to be longer if it were also based on CGM. mnkd.proboards.com/post/52801Agree. a 6-month trial probably is enough for superiority trial alone (without safety component). See the onset 3 trial below, which is a superiority trial. It lasts only 18 weeks. globenewswire.com/news-release/2015/12/09/793980/0/en/Novo-Nordisk-files-for-regulatory-approval-of-faster-acting-insulin-aspart-in-the-US-for-the-treatment-of-type-1-and-2-diabetes.htmlBagsværd, Denmark, 9 December 2015 - Novo Nordisk today announced the submission of the New Drug Application (NDA) for faster-acting insulin aspart to the US Food and Drug Administration (FDA). Faster-acting insulin aspart is a mealtime insulin for improved control of postprandial glucose excursions and has been developed for the treatment of people with type 1 and type 2 diabetes. The filing of faster-acting insulin aspart is based on the results from the 'onset' clinical trial programme which involved around 2,100 people with type 1 and 2 diabetes. In the onset programme, people treated with faster-acting insulin aspart achieved improvements in postprandial control versus NovoLog® (marketed as NovoRapid® outside the US) and an HbA1c reduction on par with NovoLog®. For people with type 1 diabetes, faster-acting insulin aspart results from the double-blinded onset 1 trial showed statistically significantly greater HbA1c reduction when dosed at mealtime or similar HbA1c reduction when dosed 20 minutes after a meal compared to NovoLog®. Across the onset trials, faster-acting insulin aspart had a safe and well tolerated profile, with the most common adverse event being hypoglycaemia, similar to the levels observed with NovoLog®. "We are happy to be able to file faster-acting insulin aspart for regulatory approval in the US and have the opportunity to address unmet medical needs for people requiring improved blood glucose control around meals," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "Onset 1 shows that faster-acting insulin aspart has the potential to offer improved postprandial glucose and either an additional reduction of HbA1c or added flexibility compared with NovoLog®." Novo Nordisk intends to make faster-acting insulin aspart available in the prefilled delivery device FlexTouch®. About faster-acting insulin aspart Faster-acting insulin aspart is a mealtime insulin for the control of postprandial glucose excursions in type 1 and type 2 diabetes as well as in pump treatment. Faster-acting insulin aspart is insulin aspart (NovoLog®) in a new formulation in which two new excipients have been added to ensure early and fast absorption. About the onset clinical programme The onset programme is a phase 3 clinical programme with faster-acting insulin aspart consisting of four trials encompassing more than 2,100 people with type 1 and type 2 diabetes. The onset 1 trial (1,143 people randomised) - a 26+26-week randomised, double-blinded, basal-bolus, treat-to-target trial investigating faster-acting insulin aspart compared to NovoLog®, both in combination with Levemir® in adults with type 1 diabetes. The results were reported in March and October 2015. The onset 2 trial (689 people randomised) - a 26-week randomised, double-blinded, basal-bolus, treat-to-target trial investigating faster-acting insulin aspart compared to NovoLog®, both in combination with insulin glargine in adults with type 2 diabetes. The results were reported in March 2015. The onset 3 trial (236 people randomised) - an 18-week randomised, open-label, basal bolus vs basal trial confirming superiority (in terms of HbA1c) of mealtime faster-acting insulin aspart in a full basal-bolus regimen versus basal insulin therapy, both in combination with metformin. The results were reported in January 2015. The onset 4 trial (37 people randomised) - a six-week randomised, double-blinded, parallel-group trial confirming pump compatibility and safety of faster-acting insulin aspart and NovoLog® in type 1 diabetes. The results were reported in August 2014. |
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Post by dreamboatcruise on Dec 16, 2015 22:34:49 GMT -5
compound26... thanks for that reference... something concrete I can use to back up my assertion in the future.
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Post by sluggobear on Dec 17, 2015 3:14:48 GMT -5
The treatment period of a study is just one component of the overall regulatory process.
I believe SueBee is adding in the usual elements of randomized, controlled, clinical trials and submission of a new IND. This would be needed if the additional claims that Sanofi expects are significant, i.e. demonstration of superiority over another product. This would require an IND.
All of the following are included in the life cycle of a clinical trial: trial design (is Sanofi just starting?) and FDA discussion, protocol approval, IRB approvals, patient enrollment, treatment period, database scrubbing and lock, analyses/statistics/report writing, and preparation/submission of the IND. Then there's the FDA review period. 24 months is typical.
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