Grapefruit USA Inc (GPFT)

[BennyJ]

My point is very clear.

1) 2008 & 2009 - Due to lot of coverage on Exposure by Radiation Devices by media - FDA Did not clear/approve radiation devices when you compare with previous years.
2) FDA was approving/clearing only Big Boys products only during those years. Medium/small/upcoming companies faced lot of obstacles in getting clearance especially in radiation devices.
3) Whoever worked on that period as device devision head & review team got terminated at the 2009 end.
4) New review took over and Dean & co have good relationship with them.
5) In 2008 & 2009 whenever IMGG submitted resubmission they had to wait for formal letter communictation/letter from FDA and had to respond for that. Now it is not the case, as they can communicate thru fax/email/phone conversations.
6) FDA is not only dealing with IMGG, it is approving 250 to 300 devices on a monthly basis.
7) FDA goals for 90 days are just goals/guideline.
8) Do research on JAK or other related product codes similar to IMGG. All are exceeding FDA's goal/guidance.
9) FDA goals and guideline document not updated after 2007. We still don't know whether the same guidelines are still hold good for 2010.
10) In my earlier post, you can see MEDTRONIC O-ARM imaging system total approval time took place 10 months. But after the last response recevied, they were able to approve within couple of days.
Thats all my points. I will hold and accumulate as much as I can.
At this point approval is any day. Risk/Reward is great. There is another catalyst within month which is buyout.