Replies to post #25979 on Grapefruit USA Inc (GPFT)

[thehawk72]

Only place I get my information is from what Dean says publicly. Listen to the MoneyTV interview he did in July. Listen to his latest CC. Not sure how posters here disagreed with me then, when I quoted Dean, word for word, no paraphrasing that he sent in a complete, entire new package. So are we going to start up the 30/60/90/150 from that date? Sorry, we can't because it's been stated here no AI was required for that submission, Dean did it all by himself, so the 150 days goes from April 5th.

[pendragon8062]

It was not a re-submission and more of a clarification. Here is what Mike N. sent me in response to that:

"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."