Grapefruit USA Inc (GPFT)

[alexdhcfx]

Found this over at the crazy yahoo's, crazy place but this seem right to me

Ok just read the new FDA document

http://www.fdanews.com/ext/files/UCM1959...

To read this, you must first read the scope statement. it tells us what this document covers. This document pertains only to image drugs used WITH image devices. It is a not a conditional statement, or a disjunct statement, it is clearly an conjunct statement.

To explain. 1+1=2. the scope of the + sign is for both #1's drug and image device. This is the scope of an conjunct (and statement). The 2 is of course the new protocol to be used, or the outcome of the statement to be more general.

it is NOT "if 1 then 2", which would be conditional

it is NOT 1 or 1 = 2 which is of curse a disjunct scope. (i think this is where the confusion comes in, nothing to be excited about it doesn't hold this logical form in the scope)
*i am just paraphrasing here, but my husband was in contract law and it really not that hard to see the logical form here, but look it up on the web if you like*


BUT: Read the scope statement first, it explains what this document is to be used for. its not if, or, but it is an AND statement

imaging drugs and imagining devices relationship (together) = what this document is all about and to add procedure for. Focus is on drugs though, but it is clear that the scope is for drugs being USED with imagine device.


This is not bad news really, if this was pertaining to IMGG then we would be even more delayed.

Also check page 10 section A and you will see the intended use is used for determination. i point this out because there has been much confusion that IMGG was a label issue, this should clear it up for good then.

It clear as day, read it for yourself.

Not good news, but not bad news, it just doesn't fit the scope and thus is nothing pertaining to DVIS

Take it as you will, not bashing or pumping. just getting the word out