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Post by sr71 on Sept 27, 2019 11:06:47 GMT -5
It's interesting that in the "Oversight" section of this document, it states: (bold emphasis is mine) "U.S. FDA-regulated Drug: Yes U.S. FDA-regulated Device: NoData Monitoring: No" Does this mean that the inhaler is not FDA-regulated? And if that is true, then why did Mannkind receive a CRL rejection for Afrezza when they switched to the Dreamboat? . . . The same inhaler that was used when Afrezza was finally approved by the FDA? |
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Post by mnholdem on Sept 27, 2019 11:11:10 GMT -5
Smart that United Therapeutics includes the Department of Veterans Affairs in the study, IMO.  |
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Post by mango on Sept 27, 2019 11:25:19 GMT -5
Smart that United Therapeutics includes the Department of Veterans Affairs in the study, IMO. Department of Veterans Affairs Greater Los Angeles Healthcare System [Not yet recruiting] Los Angeles, California, United States, 90073 Contact: Te Harold 310-268-4314 harold.te@va.gov Principal Investigator: Shelley Shapiro, MD Shelley Shapiro is a pulmonologist at UCLA. This is great news about a site being at the VA in Los Angeles. |
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Post by agedhippie on Sept 27, 2019 11:58:59 GMT -5
It's interesting that in the "Oversight" section of this document, it states: (bold emphasis is mine) "U.S. FDA-regulated Drug: Yes U.S. FDA-regulated Device: NoData Monitoring: No" Does this mean that the inhaler is not FDA-regulated? And if that is true, then why did Mannkind receive a CRL rejection for Afrezza when they switched to the Dreamboat? . . . The same inhaler that was used when Afrezza was finally approved by the FDA? At a guess this is because devices and drugs are different. Afrezza has Dreamboat integral to the drug. An insulin pump is a regulated device though because it is drug agnostic (it delivers insulin, but which insulin is not material). I suspect if you looked at the Epipen you would find that it is not a regulated device either. Why did the CRL hit when Mannkind switched from Medtone to Dreamboat? Because the effect was to modify a component of the drug and hence the need for equivalence trials. If the two inhalers had been evaluated as medical devices in their own right the CRL would have been avoided I believe. It's all about drawing scope. |
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Post by mnkdfann on Sept 27, 2019 12:24:25 GMT -5
It's interesting that in the "Oversight" section of this document, it states: (bold emphasis is mine) "U.S. FDA-regulated Drug: Yes U.S. FDA-regulated Device: NoData Monitoring: No" Does this mean that the inhaler is not FDA-regulated? And if that is true, then why did Mannkind receive a CRL rejection for Afrezza when they switched to the Dreamboat? . . . The same inhaler that was used when Afrezza was finally approved by the FDA? At a guess this is because devices and drugs are different. Afrezza has Dreamboat integral to the drug. An insulin pump is a regulated device though because it is drug agnostic (it delivers insulin, but which insulin is not material). I suspect if you looked at the Epipen you would find that it is not a regulated device either. Why did the CRL hit when Mannkind switched from Medtone to Dreamboat? Because the effect was to modify a component of the drug and hence the need for equivalence trials. If the two inhalers had been evaluated as medical devices in their own right the CRL would have been avoided I believe. Aged knows more about this than I do, but I was thinking it may be that the trial device (which isn't described in detail in the trial description online) may just not be regulated yet, meaning it has still to be evaluated and its status regarding regulation determined down the road? "United Therapeutics Corporation (UTC) is developing a combination drug-device product which is comprised of a dry powder formulation of Treprostinil Inhalation Powder (TreT) and a small, portable, dry powder inhaler." |
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Post by agedhippie on Sept 27, 2019 12:29:40 GMT -5
At a guess this is because devices and drugs are different. Afrezza has Dreamboat integral to the drug. An insulin pump is a regulated device though because it is drug agnostic (it delivers insulin, but which insulin is not material). I suspect if you looked at the Epipen you would find that it is not a regulated device either. Why did the CRL hit when Mannkind switched from Medtone to Dreamboat? Because the effect was to modify a component of the drug and hence the need for equivalence trials. If the two inhalers had been evaluated as medical devices in their own right the CRL would have been avoided I believe. Aged knows more about this than I do, but I was thinking it may be that the trial device (which isn't described in detail in the trial description online) may just not be regulated yet, meaning it has still to be evaluated and its status regarding regulation determined down the road? "United Therapeutics Corporation (UTC) is developing a combination drug-device product which is comprised of a dry powder formulation of Treprostinil Inhalation Powder (TreT) and a small, portable, dry powder inhaler." That UTHR quote is exactly what I believe - Afrezza is an insulin-device product, not an insulin product and a device product. |
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Post by mango on Sept 27, 2019 12:33:59 GMT -5
Drug-device combo, together they create synergy.
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Post by mytakeonit on Sept 27, 2019 12:42:43 GMT -5
In the eligibility section ... what does this mean?
Accepts Healthy Volunteers: No
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Post by mnkdfann on Sept 27, 2019 12:48:30 GMT -5
In the eligibility section ... what does this mean? Accepts Healthy Volunteers: No It says subjects must be diagnosed with PAH to participate, which I suppose means they are not healthy (as far as the study terms go) by default. |
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Post by falconquest on Sept 27, 2019 16:43:47 GMT -5
No, I think the above is not correct. MNKD is getting $25M per year for TreT for both 2018 and 2019 which is paid in two installments of $12.5M in each year. MNKD is yet to receive the 2nd installment for TreT for 2019 but should receive it before the end of this year. Spencer O schedules it in September in his latest article. The payment for the "undisclosed molecule" of $15M (if memory serves) is as yet undetermined or at least undisclosed. Should this be announced soon it will be in addition to the $12.5M and further enhance MNKD's much improved cash position and extend its runway. As some have already noted even Spencer O has turned positive. Likely to avoid looking foolish now that MNKD has a vastly improved future outlook. If he has been negative for the time period when MNKD shares lost a huge portion of their value and then calls it right on the final turn around, he will look like a genius compared to most people opining about MNKD (myself included). But regardless of the whether he's right on the turnaround, he deserves credit for being the correct one up until now. The turn around will happen when Mannkind licenses out Afrezza to someone who can sell it and continues to develop new Technosphere molecules. It's time to move this company forward! |
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Post by ktim on Sept 27, 2019 16:58:08 GMT -5
If he has been negative for the time period when MNKD shares lost a huge portion of their value and then calls it right on the final turn around, he will look like a genius compared to most people opining about MNKD (myself included). But regardless of the whether he's right on the turnaround, he deserves credit for being the correct one up until now. The turn around will happen when Mannkind licenses out Afrezza to someone who can sell it and continues to develop new Technosphere molecules. It's time to move this company forward! The catch 22 is likely that licensing may not be an option until the point when it would no longer make sense. |
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Post by Clement on Sept 29, 2019 11:59:14 GMT -5
clinicaltrials.gov/ct2/show/NCT03950739?term=tret&recrs=ab&cond=PAH&cntry=US&rank=1The four sites are : "Locations United States, Alabama University of Alabama at Birmingham Recruiting Birmingham, Alabama, United States, 35233 Contact: Brittany McCullough 205-975-8519 bejohnson@uabmc.edu Principal Investigator: Robert Bourge, MD United States, California Department of Veterans Affairs Greater Los Angeles Healthcare System Not yet recruiting Los Angeles, California, United States, 90073 Contact: Te Harold 310-268-4314 harold.te@va.gov Principal Investigator: Shelley Shapiro, MD United States, Kansas The University of Kansas Medical Center Recruiting Kansas City, Kansas, United States, 66160 Contact: Luigi Boccardi 913-588-4022 lboccardi@kumc.edu Principal Investigator: Leslie Spikes, MD United States, Kentucky University of Louisville Pulmonary Research Not yet recruiting Louisville, Kentucky, United States, 40202 Contact: Joan Hamlyn, RRT 502-852-8739 Joan.hamlyn@louisville.edu Principal Investigator: Karim El-Kersh, MD"
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Post by harryx1 on Oct 1, 2019 11:49:13 GMT -5
more locations...
Locations:
United States, Alabama
University of Alabama at Birmingham
[Recruiting]
Birmingham, Alabama, United States, 35233
Contact: Brittany McCullough 205-975-8519 bejohnson@uabmc.edu
Principal Investigator: Robert Bourge, MD
United States, California
Department of Veterans Affairs Greater Los Angeles Healthcare System
[Recruiting]
Los Angeles, California, United States, 90073
Contact: Te Harold 310-268-4314 harold.te@va.gov
Principal Investigator: Shelley Shapiro, MD
United States, Florida
University of South Florida
[Not yet recruiting]
Tampa, Florida, United States, 33606
Contact: Rachel Karlnoski 813-396-9172 rkarlnos@health.usf.edu
Principal Investigator: Ricardo Restrepo, MD
Cleveland Clinic Florida
[Not yet recruiting]
Weston, Florida, United States, 33331
Contact: Lilian Cadet 954-659-6215 cadetl@cff.org
Principal Investigator: Jinesh Mehta, MD
United States, Kansas
The University of Kansas Medical Center
[Recruiting]
Kansas City, Kansas, United States, 66160
Contact: Luigi Boccardi 913-588-4022 lboccardi@kumc.edu
Principal Investigator: Leslie Spikes, MD
United States, Kentucky
University of Louisville Pulmonary Research
[Recruiting]
Louisville, Kentucky, United States, 40202
Contact: Joan Hamlyn, RRT 502-852-8739 Joan.hamlyn@louisville.edu
Principal Investigator: Karim El-Kersh, MD
United States, Louisiana
Ochsner Medical Center
[Not yet recruiting]
New Orleans, Louisiana, United States, 70121
Contact: Cindy Fontenelle 504-842-1935 cindy.fontenelle@ochsner.org
Principal Investigator: Stacy Mandras, MD
United States, Pennsylvania
University of Pennsylvania
[Not yet recruiting]
Philadelphia, Pennsylvania, United States, 19104
Contact: Tess LaPatra 215-294-9755 Tess.Lapatra@Pennmedicine.upenn.edu
Principal Investigator: Harold Palevsky, MD
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Post by Clement on Oct 3, 2019 8:14:18 GMT -5
Now 8 locations.
45 participants.
on average, about 6 participants per location.
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Post by harryx1 on Oct 25, 2019 13:03:18 GMT -5
2 new locations added...
United States, Georgia
Emory University Hospital
[Recruiting]
Atlanta, Georgia, United States, 30322
Contact: Jane Gillespie, RN 404-712-8204 jane.gillespie@emory.edu
Principal Investigator: Micah Fisher, MD
United States, Texas
Houston Methodist
[Not yet recruiting]
Houston, Texas, United States, 77030
Contact: Jennifer Lee 713-363-7537 jllee@houstonmethodist.org
Principal Investigator: Sandeep Sahay, MD
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