Replies to post #25325 on Grapefruit USA Inc (GPFT)

[BennyJ]

There are 2 performance goals for 510k medical device approval process starting from 2007 thru 2012
1) issue decision(SE(approval) or NSE(denial)) within 90 days or less for 90% of the applications
2) issue decision within 150 days for 98% of the applications.

In the 2009 last quarter and 2010 first quarter FDA performance reports, FDA achieved 100% decisions within 150 days. That means after new review team & device devision head took over this year beginning, they exceeded their goal(98% within 150 days) which is 100% decisions.

If we expect similar performance for the second quarter, then FDA should clear/approve Dominion since April 5th(submitted date) and April 9th(receipt date) sooner.

I expect finally, time has come for Dominion DVIS to get clearance now.

Other reasons for clearing/approving Dominion DVIS are...
- it was long pending application for no reason.
- it should have been approved an year earlier
- last review team didn't do good job on clearing the innovative new devices in 08 and 09.
- There was a huge buzz by the media about radiation emitting devicess in 08 & 09. FDA literally shut off new clearance on radiation emitting devices for no reason even though they were SE to existing marketted devices. Even they shut off new devices from big players. Either they took long period of time to approve or approved only devices with the upgrade.
- Dominion DVIS has already got IDE(Investicational Device Exception) clearance in 2008. so they cannot just approve IDE and move on any more. Imaging3 and Dean's team and lot of long time investors have come to this stage after lot of patience thru this hard time.
- future potentional and buyout offer - you can't just imagine what it is going to be. That is the seperate thread in which we need to discuss.
- I have been interacting with the company in regular intervals. You can mail or phone them and they can answer whatever questions you can ask.
- oh, I forgot, the last and most important one is radiologist report for the images to prove SE. it was submitted with April 5th submission. It is the last stage of approval on 510k clearance especially for imaging devices when the technological charateristics changes from the existing devices.

[DonKeyhoti]

September 9th is 150 days from the last formal 510k submittal. The FDA created this objective to notify applicants within this time frame. They have hit this time frame almost every time.