What about costs of clinical trials

[doodyfree]

What about the clinical trials?  The longer term safety isn't due until 2023, but runs 5 years, that means MNKD will need to to start recruiting 2017.  

1) What are the estimates on costs for the rest of the near term trials?

2) Can we ask for a delay in the longer term trial?

[doodyfree]

Also, is MNKD immediately responsible for the clinical trial costs ?  Or only after the termination period?

[Deleted]

pediatric trial is equally more important if not even more.

[mnkdmorelong]

Jan 5, 2016 23:02:42 GMT -5 doodyfree said:

What about the clinical trials?  The longer term safety isn't due until 2023, but runs 5 years, that means MNKD will need to to start recruiting 2017.  

1) What are the estimates on costs for the rest of the near term trials?

2) Can we ask for a delay in the longer term trial?

Ah, it is costly to have total control of Afrezza.  SNY bailed before Safety Study costs started.  

MNKD is working on the Plan. We should know more next week.

[peppy]

Jan 5, 2016 23:06:45 GMT -5 @iam2sekc4u2002 said:

pediatric trial is equally more important if not even more.

agreed: the 8 week data should have been completed. The 1 year treatment extension should be minimal cost.

I wonder trials are somehow addressed in the partnership agreement.

.

Detailed Description:

The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit.

Patients who completed 4 weeks of Afrezza treatment and have shown to be safe and well controlled with Afrezza + basal insulin will have the option to continue the extension treatment up to 1 year.

Estimated Enrollment: 46
Study Start Date: October 2015
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)

clinicaltrials.gov/ct2/show/NCT02527265?term=afrezza&recr=Open&no_unk=Y&rank=17

Verified December 2015 by Sanofi

Sponsor:

Sanofi

Information provided by (Responsible Party):

Sanofi

[matt]

The license agreement is clear; the partnership split the cost of clinical trials and now MNKD is on the hook for 100% of the cost. I think an argument can be made that Sanofi must fund 65% for 90 days, but nothing beyond that point. MNKD is on the hook for the pediatric and long-term safety studies, and getting meaningful extensions out of the FDA would be difficult, and the EMEA is even tougher than FDA on pediatric results.

The cost of the trials depends exactly on what testing is required, number of follow-up visits and, especially, any imaging. Few trials get done for less than about $20,000 per subject (all inclusive cost) and trial with a lot of imaging can easily run well past $50,000 per subject. If I had to make an educated guess, I would put the number toward the lower end of the range (i.e. about $25,000) but that is purely a guess based on clinical trials I have managed in the past and my assumptions about what is likely to be required.

[jpg]

The 54 patient paediatric study is minor from a financial point of view.

The problem is the safety study. Using your reasonable (and conservative) 20000$ per patient and multiply that by 5000 (or 10000) and you quickly see where this becomes a big and very expensive issue...