Replies to post #47066 on Grapefruit USA Inc (GPFT)

[xtrachz]

Hang on to your shares boys and keep your powder dry!

Long and strong to the final gong is the victory song!

XC

[Chemic76spirit]

It actually means ABSOLUTELY NOTHING! Dean is submitting a proposal {for} a proposal- he is making on how the FDA is going to give clearance for the DViS. It is nothing more; neither does the FDA have to accept his proposal for them to have a face to face on his proposal! The pps will soon drop even lower than before.

[KingKong_Guru]

Lamb,

I think , FDA may respond within 2-3 week , stating time slot for 1-2 hour face to face FDA meeting.

Actual meeting will happen sometime in October (my best guess).
In next six week FDA will go through PRE meeting documents , and proposed image comparison protocol developed by imaging consultant .
FDA will prepare memos , and other documents to prepare for meeting.

Dean and consultant will present their case to FDA in face to face meeting and ask very specific question pertaining to 510k application.

Meeting will help in last minute modification in 510k application , as well as to acquire images as per agreed imaging protocol.

I guess , 95% 510k application is done and kept in a vault.
It is just matter to attaching imaging document with the application and send it to FDA.

I see submission sometime in mid Nov-11 time frame.

Overall IMGG is going in right direction ......DVIS is 100 % NSR & 510k device .....their is no question of PMA or human clinical trials.

KKG