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Re: blackbandit post# 5527

Friday, 08/05/2016 10:22:43 AM

Friday, August 05, 2016 10:22:43 AM

Post# of 6306
In my opinion this is the reason for the delay in enrollment...

From the 10q:

"During the interactions regarding the approval of the expansion of The INSPIRE study to enroll up to 30 patients, the FDA recommended that we include a control arm in the study as part of a study design consideration. At the present time, we are in discussions with the FDA regarding this recommendation."

I believe they are just being cautious and making sure they iron out exactly what the FDA will need in order for approval.
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