Replies to post #33929 on Grapefruit USA Inc (GPFT)

[ANTman2015]

the FDA will need a very good reason to withdraw its determination of NSE in order to maintain its credibility as a regulatory body

[mr_sano]

Guys the device needs clinical data...in what form or how that is carried out is the question, It took months to get a radiologist report for which the company paid for and is likely just a simple review with no real guidance form the FDA. I'n sure the agency needs a comphrehesive report with detailed imagery to support all the DVIS claims. It will take at minimum 3-6 months for DEan to get this info. It will take 3-6 months for the FDA to repsond. I woudl say the time frame is 6-13 months before we are facing an answer from the fda.