Replies to post #1793 on Grapefruit USA Inc (GPFT)

[TASHI]

Thanks for your description of the IDE.

I'm wondering if Dean is able to offer some insight on this recent development?

One question that I have pertains to the progress that was made towards satisfying the FDA during their 9 month evaluation? Are they 80% to 90% satisfied? How much additional documentation is needed to completely satisfy the FDA, and the time factor involved?

Can the I3 team, along with the IDE studies, provide this data regarding "clinical imagery and functionality" to the IDE investigator in an expedited manner? Also, how many IDE sites will be involved and does I3 have Dominions available for the submission of this additional documentation to the FDA?

I'm long IMGG and have complete confidence in Dean & Company. However, I think it's good for everyone to have a better understanding in this uncharted terrority.

Thanks,