Replies to post #48977 on Grapefruit USA Inc (GPFT)

[mr_sano]

Actually I this is the jist of it all:

Of primary importance, our team confirmed with the FDA that our submission will be a 510(k) as we had predicted. The 510(k) approval process is the most advantageous submission for Imaging3 to pursue, since it provides the shortest route to a potential approval and includes neither complicated nor time consuming clinical trials. The Agency has asked us to provide live patient data, which was a possibility we anticipated and under the 510(k) process this requirement is manageable.

Its not really a point from where I sit. The FDA perspective is most likely the same...it's just like every other new submission. All of the submission requirements are public knowledge available to anyone with a computer. The real meat and potatoes can will be if Dean can explain in detail the algorithm and updating issues which the FDA have serious question about in NSE 1-3. The patent is unclear on how this is all accomplished and even our resident technological guru can;t explain it in the most basic terms. At some point in time Dean will need to reveal how his device processes and renders this imagery in various modes and what techniques they use to output. MIP,VRT..in REAL TIME.


On the direct communication blip...again no real surprise. I don;t even think a phone call is allowed to reviewers during the review. I'm sure there is are case for a call for a discussion...but Dean can;t just pick up the phone and say "Need Anything?The protocols is the only piece of info worth releasing but again I believe that information was previously known. I'm sure if you dig deep enough you will find it. The only good thing I can see is that Dean finally realized he has to PR news events. Why it was PRECEDED by an MTV spot is again completely irresponsible.