Replies to post #9784 on BioCurex, Inc.(fka BOCX)

[Ted F]

Sleeper, you don't know BOCXMAN by any chance, do you?

[Gold Seeker]

Sleeper, If they try a 510(k), you might not hear about the submission because I cannot find any website that gets the information from the FDA/CBER records. It is public information and you could check the records in Maryland to confirm.

As for a PMA submission, they will definitely run clinical trials and those are indeed published on the internet. As an example:
http://clinicaltrials.gov/ct2/show/NCT00008346?spons=%22American+College+of+Radiology+Imaging+Networ....

IMO, there is no predicate for this test to use a 510(k) and they have not run any clinical trais for a PMA.

I would take what Terry says with a grain of salt on technical issues of FDA submissons, etc. He probably knows less than we do. If he says he has spoken with Dr. Moro about the subject, that would be different but in this case, he has not even talked with him in the last two weeks.