Replies to post #23487 on Grapefruit USA Inc (GPFT)

[IMGGorBust]

Thanks, Pen. Here's a repost of the post your are referring to:

Post # of 23487
Posted by: pendragon8062
Date: Thursday, July 22, 2010 7:05:35 PM
In reply to: thehawk72 who wrote msg# 20941

This is what Mike replied with to me when I asked him the question:

"What Dean sent the FDA was on his own initiative not at the request of the FDA for a formal resubmission like we had to do for the new review team in April. My understanding – and if my understanding is off-base in any way I’ll let you know – is that Dean annotated the document so that the reviewer could connect the dots faster. The prior review team had asked for some non-standard things (for lack of a better phrase) and these requests from Team #1 complicated things for Team #2. It was just easier for Dean to expand the table of contents with more specific information and then tag those sections in the document. This would be best accomplished by simply giving them another copy of the full document with annotations and other explanatory text to help this reviewer understand the structure of the document which has become very large."

[ltt05]

from pendragons old posts...

This is what Mike replied with to me when I asked him the question.

"What Dean sent the FDA was on his own initiative not at the request of the FDA for a formal resubmission like we had to do for the new review team in April. My understanding – and if my understanding is off-base in any way I’ll let you know – is that Dean annotated the document so that the reviewer could connect the dots faster. The prior review team had asked for some non-standard things (for lack of a better phrase) and these requests from Team #1 complicated things for Team #2. It was just easier for Dean to expand the table of contents with more specific information and then tag those sections in the document. This would be best accomplished by simply giving them another copy of the full document with annotations and other explanatory text to help this reviewer understand the structure of the document which has become very large."