Grapefruit USA Inc (GPFT)

[Dr. Mugs]

Consulting firms like King and Spalding and UL have a high approval success rate with the FDA. They might be able to get approved through the De Novo process but they only have 30 days from the date on the NSE letter. So, they better not take too much time hiring someone. If that does not work then they will be forced to do the IDE. They made a big mistake asking for the IDE approval, getting it and then not following through with the testing. He just bit off more then he could chew in regard to doing the 510k alone. A consulting co will want to make sure the device is working So, it will be a hugh plus when that announcement is made. If the device is not working then this will be the end of the line.