BioCurex, Inc.(fka BOCX)

[Gold Seeker]

Opportunity, Burger is making a fairly complicated process over simplified. You don't just file a 510k.

You also will not be able to find any application you apparently are planning to watch for. The FDA only publishes approved applications and by that time, the company would be screaming to the high heavens they had FDA approval.

First things first. Once you have a product developed, you meet with the FDA and come to some sort of agreement on what trials need to be run and how extensive they need to be. Then you do the trials and write up an application showing that it is nearly identical to another approved product. If you cannot prove that it is closely identical to another product, then a 510k will not be accepted.

IMO, the company is being very optimistic saying the RECAF POC device would be a Class II device. Everything I have read on the FDA website points out that cancer tests are class III but that decision would be up to the FDA.

Burger's prepared remarks came very close to what was in the press release. Some good questions were asked.