Grapefruit USA Inc (GPFT)

[Homer Simpson]

The biggest problem as I stated is that Dean's ego would not allow him to ask for help. Now that his ego got deflated enough and he has consultants on board to be sure he is following the steps correctly, the submission should be what they are looking for.

As we all know by now, the FDA has been going through changes to the reviewers and the approval process as written here:
http://www.farmpd.com/Farm-Blog/?Tag=medical%20device%20industry

It is thought that the current FDA environment has gone too far with a current zero risk tolerance policy in order to satisfy reviewers. New reviewers have little experience with the 510(k) process, which has left medical device companies feeling the pain of a lengthy review process and unpredictable requests and submission guidelines.

Longer approval times and unclear submission requirements can result in costly development overruns. This is a concern for not only the medical device community but for the investment community as well. Recently Massachusetts Medical Device Journal (MassDevice) surveyed a group of New England med-tech investors and found that the FDA changes were the primary concern for investors when considering investment into the med tech sector.