Replies to post #25292 on Grapefruit USA Inc (GPFT)

[ndforlife]

Better read TT05 post again.. That is not what he said..

The whole CDRH division of the FDA was replaced at the beginning of the year, and since they have been replaced (the last two quarters), decisions have been reached 100% of the time within 150 days.

[ltt05]

The 150 day timeframe is guidance for the FDA review teams. So, the FDA aims to reach a decision within 150 days. They set up this arbitrary time frame.

[IMGGorBust]

It's a specific goal against which the FDA measures it's performance. They have a goal to get formal responses back 98% of the time within 150 days, and so far, since the new CDRH came into power, they have exceeded the goal by getting back formal responses within 150 days 100% of the time. It's not an arbitrary number. Check out the FDA's website.