Replies to post #25386 on Grapefruit USA Inc (GPFT)

[ysung]

I don't mean to doubt that but how did
you know Jeff was on conf call with
dean ?

[Maddog720]

Very much agreed however there is a "Chain of Command" in every organization. That's why when things don't go right, they are the ones who are ultimately responsible and their heads get cut off.

Things are delagated to those that fall below the "top dog" but it is the top dog, with the wisdom and expertise of others, that put their seal of approval on the package.

[mr_sano]

And Becky is running a down and out looking for the 50 yd Faxbomb!
Guys where do you get such first hand knowledge?

[IMGG4TP]

BUST, I know you want to get the Director of the CDRH and Shuren in on this conversation, but nobody is questioning his title and authority. The subject of Hindsight's query, as you acknowledged in #25372, was Rosecrans, the Director of the 510(k)Office of Device Evaluation, and it is clear, if you read the news release carefully, below, that she and her office are not only in the loop, but at the center of the decision making process, and therefore, by extension, have a considerable influence on the final destination of Dean's application.


"A major player in CDRH’s 510(k) process is stepping down just as the agency begins to revamp the device clearance program. Heather Rosecrans, director of CDRH’s 510(k) Office of Device Evaluation, is retiring Sept. 15, FDA spokesman Dick Thompson said. Her departure could be another example of the ongoing turnover at CDRH, John Romans, CEO of BioMedix Vascular Solutions, said, adding that the turnover has resulted in a loss of institutional memory, contributing to the lack of predictability in the clearance process."