Grapefruit USA Inc (GPFT)

[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.