Replies to post #19816 on Grapefruit USA Inc (GPFT)

[pendragon8062]

As many days as the FDA wants it to have. As Bust has stated multiple times, the 30-60-90 day timelines are internal FDA guidelines only. Sometimes they meet them, sometimes they don't, but they don't represent any type of obligation to return an answer by that point in time.

It's like turning in your homework. Once it's in, it is up to the discretion of the teacher to return it in 3 days, 3 weeks, or 3 months.

If it doesn't come back in a timely manner, all the student can do is ask politely when they might get it back, wait, and ask again with the risk each time they upset the teacher.

There is no accountability in this system and as anybody who has worked with governtment agencies knows, competence and timliness are NOT two qualities you'll find in high quantities.

[IMGG4TP]

Precisely my sentiments, wiz! I thought the 90 day period ended two weeks ago. IMGGorBust, help us out here. When does this 90 day period end?

[Admiral38]

I suppose that's a valid question. The 90 days that ends tomorrow is 90 calendar days after the last submission of material, you know, the radiologists' opinions and the corrections to the labeling. The FDA officially received that material on 9 April last. Up to that point, we had been assured, multiple times, that approval was imminent. The 90-day period has been bruited about on this board on and off for some months as if it were a (1) target date, (2) rough estimate or (3) totally without significance because the FDA has no system of target dates and we shouldn't expect anything at all from them.

So take your choice. Personally, I realize that getting involved in this thing may have been the biggest financial mistake of my life. If tomorrow passes without a happy word, I will drop the words "may have."