Grapefruit USA Inc (GPFT)

[ltt05]

Here is the timeline

April 2, 2008
FDA approval for investigational distribution.
“This approval to distribute the Dominion Vi Scanner is for investigational purposes only allowing the company to glean clinical imagery and functionality during the FDA 510(k) approval process"

Many awards following this announcement.

July 6, 2009
Conference call updating investors on FDA progress.
"Mr. Janes reviewed the Company’s progress to date on a number of substantive initiatives, including; intellectual property, new product developments and the company’s progress with the FDA. Mr. Janes’ presentation was followed by a lengthy question and answer session."

August - December 2009
Many conference calls held as the FDA process took a turn for the worse and started to get tricky.

January 12, 2010
Conference call regarding the FDA asking for new information.
"The purpose of the call is to update Shareholders and other interested parties of the current developments with the company’s 510k FDA submission. Currently the FDA has requested further information and Mr. Janes would like to discuss the company’s plans to address these questions."
During this call, we learned that the FDA people reviewing the DViS 510k were replaced by new people. Hence, a new packet submittal and an obvious reason for a delay.

April 5, 2010
Dean submits new information to the FDA. The FDA clock restarts.

August 12, 2010
Most recent conference call in which Dean stated that the FDA has not formally requested anything new, so the clock has been ticking since April 5. Therefore, 150 days is up around September 8.