InVivo Therapeutics Holdings Corp (NVIVQ)

[Perkin78]

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.