|
|
Post by kc on Oct 1, 2016 12:59:23 GMT -5
Received notice from Mike C. That MannKind would have two associates working that event Sunday Morning October 2nd. I happen to be in St. Louis visiting family and will stop by and take a few pictures. See the sample Technosphere inhalers. Anybody in the St. Louis drop me a PM and we can meet up. MIke also indicated there is one upcoming in Louisville they will be exhibiting at in the future. "Louisville, Kentucky JDRF Walk is scheduled for 10/15 and we are planning to have a booth there as well." . St. Louis event: ABOUT JDRF ONE WALK® JDRF One Walk® has a single goal: creating a world without type 1 diabetes (T1D). We hope you'll join us this year as we walk and raise money for life-changing research for the millions affected by this devastating disease. More DATE AND TIME October 02, 2016 Check-in: 8:30 AM Starts: 9:30 AM Length of walk: 1 and 3 Mile LOCATION MilliporeSigma 2909 Laclede Ave Saint Louis, MO 63103 www2.jdrf.org/site/TR/Walk/GreaterMissouriandSouthernIllinoisChapter4336?pg=entry&fr_id=6305 |
|
|
|
Post by kc on Oct 1, 2016 21:17:39 GMT -5
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Oct 2, 2016 18:15:25 GMT -5
Were Afrezza t-shirts being handed out?
|
|
|
|
Post by kc on Oct 2, 2016 20:10:18 GMT -5
No JDRF to registered walkers.
|
|
|
|
Post by kc on Oct 2, 2016 22:42:45 GMT -5
Last take away for the day. Since the event was a juvenile diabetes research foundation Walk,most of the people in attendance had kids under age 18. The excitement of the kids when they learned about inhaled insulin was really nice to watch in their eyes. What's the disappointment was, they learned they had to be at least 18 to use it. The same phenomenon applied to the parents. Once MannKind completes trials and gets FDA approval for under 18 news we will see explosion of opportunity.
There was genuine excitement by anybody who stopped by the booth to learn about Afrezza from Brett N.
|
|
|
|
Post by gamblerjag on Oct 2, 2016 23:07:50 GMT -5
Hey KC. Thanks for the updates this weekend.. Do you think family members of diabetic children were able to put their names (emails) with Mannkind Cares. Do you know if MNKD is getting these parents information so when or if pediatric trials are approved they won't have to start from scratch and wait for parents to contact MNKD? They will have all the names of parents with Diabetic children and they can give them updates???.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Oct 2, 2016 23:09:17 GMT -5
How long would the pediatric trials take? Sorry in advance if this is already posted.
|
|
|
|
Post by gonetotown on Oct 3, 2016 10:04:23 GMT -5
How long would the pediatric trials take? Sorry in advance if this is already posted. If it's like the Sanofi trial was that was discontinued: "Study Start Date: June 2015 Study Completion Date: September 2015" Then factor in a few months to compile data, analyze, submit to the FDA -- maybe 6 months total? |
|
|
|
Post by mnholdem on Oct 3, 2016 10:27:26 GMT -5
How long would the pediatric trials take? Sorry in advance if this is already posted. Applicant:MANNKIND CORP
Product:Afrezza (insulin human) inhalation powder
NDA/BLA Number:22472
NDA/BLA Approval Date:06/27/2014
Annual Report Due Date: (must be submitted within 60 days of this date) 06/27/2016
Annual Report Received:08/25/2015
Requirement/Commitment Number: 1
Required Under:Pediatric Research Equity Act
Original Projected Completion Date: 01/31/2021
Description:
An open-label pharmacokinetic (PK), and multiple-dose safety and tolerability dose-titration trial of Afrezza in pediatric patients ages 4 to 17 years (inclusive) with type 1 diabetes (Part 1), followed by a prospective, multicenter, open-label, randomized, controlled trial comparing the efficacy and safety of prandial Afrezza to prandial subcutaneous insulin aspart used in combination with subcutaneous basal insulin in pediatric patients 4 to 17 years old (inclusive) with type 1 or type 2 diabetes (Part 2). Part 2 of the trial should include a 4-week run-in phase and a 52-week randomized intervention phase.
Current Status:Pending
Explanation of Status:The study has not been initiated, but does not meet the criterion for delayed.
Source: www.accessdata.fda.gov/scripts/cder/pmc/index.cfm
---
Part 1 = 4-6 months Part 2 = Approximately 56 weeks
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Oct 3, 2016 10:32:55 GMT -5
Great cheap way to get in front of people and get them a spirometer test done. Pretty clever. |
|
|
|
Post by gonetotown on Oct 3, 2016 11:14:32 GMT -5
How long would the pediatric trials take? Sorry in advance if this is already posted. Applicant:MANNKIND CORP
Product:Afrezza (insulin human) inhalation powder
NDA/BLA Number:22472
NDA/BLA Approval Date:06/27/2014
Annual Report Due Date: (must be submitted within 60 days of this date) 06/27/2016
Annual Report Received:08/25/2015
Requirement/Commitment Number: 1
Required Under:Pediatric Research Equity Act
Original Projected Completion Date: 01/31/2021
Description:
An open-label pharmacokinetic (PK), and multiple-dose safety and tolerability dose-titration trial of Afrezza in pediatric patients ages 4 to 17 years (inclusive) with type 1 diabetes (Part 1), followed by a prospective, multicenter, open-label, randomized, controlled trial comparing the efficacy and safety of prandial Afrezza to prandial subcutaneous insulin aspart used in combination with subcutaneous basal insulin in pediatric patients 4 to 17 years old (inclusive) with type 1 or type 2 diabetes (Part 2). Part 2 of the trial should include a 4-week run-in phase and a 52-week randomized intervention phase.
Current Status:Pending
Explanation of Status:The study has not been initiated, but does not meet the criterion for delayed.
Source: www.accessdata.fda.gov/scripts/cder/pmc/index.cfm
---
Part 1 = 4-6 months Part 2 = Approximately 56 weeks
Curious that from the link provided: "Requirement/Commitment Number: 2 Required Under: FDAAA Section 505(o)(3) Original Projected Completion Date: 03/31/2017 Description: Conduct a dose-ranging PK-PD euglycemic glucose-clamp trial to characterize the dose-response of Afrezza relative to subcutaneous insulin in patients with type 1 diabetes. Select at least three to four doses for each route of insulin administration to ensure both the linear and curvilinear portions of the dose-response curves are adequately captured and characterized. Compare the dose-response curves for Afrezza and subcutaneous insulin noting the dose at which the response becomes curvilinear for each. These data may impact labeling recommendations for dosing and thereby mitigate the risk of diabetic ketoacidosis, which has been observed with Afrezza. Current Status: Ongoing" "Requirement/Commitment Number: 3 Required Under: FDAAA Section 505(o)(3) Original Projected Completion Date: 01/31/2017 Description: A PK-PD eugylcemic glucose-clamp trial to characterize within-subject variability for Afrezza pharmacokinetic (PK) and pharmacodynamic (PD) parameters. These data may impact labeling recommendations for glucose monitoring and thereby mitigate the risk of hypoglycemia, which has been observed with Afrezza. Current Status: Pending" So MNKD hasn't yet reported the results of those two? |
|
|
|
Post by mnholdem on Oct 3, 2016 11:16:08 GMT -5
That was supposed to have been Sanofi's job - they ran these trials.
|
|
|
|
Post by gonetotown on Oct 3, 2016 11:16:40 GMT -5
Great cheap way to get in front of people and get them a spirometer test done. Pretty clever. I would doubt that a doctor would accept results of a spirometry test done at a health fair. |
|
|
|
Post by gonetotown on Oct 3, 2016 11:18:32 GMT -5
That was supposed to have been Sanofi's job - they ran these trials. Wouldn't argue with that, but shouldn't Mannkind go ahead and report them anyway? |
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Oct 3, 2016 11:22:34 GMT -5
Great cheap way to get in front of people and get them a spirometer test done. Pretty clever. I would doubt that a doctor would accept results of a spirometry test done at a health fair. I don't know. I am not a Dr so I cant say for sure. I am sure disclosures come with the results that would put blame on MNKD shoulders vs the Dr if something ended up happening to patients with lung problems. |
|
