NanoLogix Inc (NNLX)

[Abig]

My response to that post other there but it won't allow me to post it.

Sunlover
The way I understand it is as follows
A study is done and the findings of the study are used to apply for FDA approval.
After review of the study information and the application the FDA gave approval in the form of the 510k exemption.
Now a clinical trial is needed to solidfy the fact put forth in the study.
this is an exerpt from the FDA website

"The development of this clinical trial guidance resulted from a concern about the quality of clinical trials submitted to the Agency in support of medical device applications. This concern applied to many critical elements of clinical trial design, conduct, and analysis and was supported by the findings of the Committee for Clinical Review chaired by Dr. Robert Temple, Ann Witt served as co-chair, whose report became publicly available in March 1993. The CDRH recognized the need for a separate guidance document to address these concerns, and to clearly document those elements needed for a well designed, conducted, and analyzed device clinical trial."

So basicly the FDA wants info from third parties to prove that the study was not faked or provided false information. If you want more info go to the FDA website and do some research.

Andre