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Message: Re: Email From Matt Pfeffer

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Jun 16, 2012 09:59PM

Hi,

This is my first post in Mannkind board :-)

I am a biostatistician working in pharma/biotech industry. I hope my input can help you understand what is going on with two phase 3 studies.

type 1 diabetes study: http://www.clinicaltrials.gov/ct2/show/NCT01445951?term=mannkind&rank=6

As you can see in the official title, this study is an "open"-label study, which means treatment assignments are not blinded. Considering different mode of delivery/device, it makes sense to run a study this way.

type 2 diabetes study: http://www.clinicaltrials.gov/ct2/show/NCT01451398?term=mannkind&rank=7

This is a double-blind, placebo-controlled study. Patients will receive and take either Technosphere Insulin (Afrezza) or Technosphere inhalation powder (placebo). Therefore, the sponsor would not know the treatment assignment until the study is completed.

Based on the information above, I think it is possible that Mannkind could use the accumulating data from type I diabetes study in partnership discussions. However, it makes sense not to disclose the data in the public to maintain integrity of the trial until the study is completed.


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