Replies to post #25447 on Grapefruit USA Inc (GPFT)

[Lambster]

Well that would only make me more confident in our situation, since if my understanding is correct, the DVIS had approximately 18 issues that the FDA came back with prior to last submission in April, which all have been resolved or clarified, with the last item being the radiologist's review, which we all know was acceptable at the very least.

In Dean's last CC he stated he had conversation with the reviewer as recently as a couple days priopr to the call. At that time no further information or clarification on ANYTHING was asked for and the reviewer gave the standard response that the application was still in review.So, the issues asked for have been resolved, the FDA has asked for no additional information, and we are a week away from a guideline time frame for a response that the FDA has hit 100% of the time in the last two quarters. The new review team cannot share pertinent information prior to an official decision because they can't, but AGAIN, they have asked for nothing additional.

The current PPS for this stock is currently how much??? Is there any question the impact that this DVIS will have in the medical field once approved?? The logic it takes to decide which side of the fence to be on with this one is almost laughable, considering the risk / reward involved!! All of the negativity about how long this process has taken is completely understandabe, but if you look at where this process sits today, I would be very nervous being on the outside looking in as a critical date rapidly approaches.

[BennyJ]

WHY?! You need to ask that question to the CEO of NEPH. What has he been hiding? Ask him? You will know answer.

Ask them these questions.

1) Is that device De nova device? Or the new fda proposal(class IIb device?)
2) Is that coming under existing product code or need to be reclassified.
3) Is there a predicate available?
4) Is there data available to check safety and efficacy of the data? Did they request performance data?

2008 and 2009 is the worst years for fda clearance on rediation devices and not for NEPH related industry - (purifier related)
something wrong in there.

I know, in recent boston medical devices & FDA meet some one was complaining about one PACS software system was awaiting approval news for almost 22 months. one or few here and there. But not a lot.

In IMGG case, it is the last stage which verifies performance data. After April 5th submission, FDA and Dean has been interacting very well and communication is the key.

[NORTH LAND]

Today is truly going to mark the last day to get into IMGG
The train is boarding and is ready to depart the Station!
This device is revolutionary!
I honestly think this could see 7 dollars with approval!
Buyout will bring 12 bucks!