Paradigm Medical Industries Inc. (PDMI)

[Dubb10]

Other companies may have interest in the device, but one problem is that the device was not created by PDMI.

If we go into the new year without any updates, then I will begin to be skeptical about 510(k) clearance any time soon. 90 days will have been, or already have been reached by the end of this week. People should also be aware that 90 day window doesn't follow the initial application submission. It is a resettable clock if the FDA should request more data. As I have posted here before (until the mods deleted it), dealing with the companies that I've been following, the FDA has been relatively on time with most decisions this year. The problem is that companies don't always readily inform investors when the FDA asks for more data. They don't necessarily have to tell investors. They will simply say that they are still waiting on FDA clearance/approval. If the FDA requests more data, that will be bad but not horrible. If the FDA labels the device at Not Substantially Equivalent (NSE), that is really bad. I've heard, "...it appears there are no major obstacles standing in the way of receiving 510(k) approval from the FDA..." before from another company that I have been following and that belief is not a lock that they will get clearance. That other company got a NSE notification and they have been trying to get a new 510(k) clearance. It has been over 1 year since the initial 510(k) application. I'm not saying that this will be the case with PDMI and CSO, but the possibility is there. The FDA has to go over much more data than what is usually disclosed to investors.

I'm also not convinced that the PPS will see significant movement on a clearance with the current share structure. I do think it will see some action. If I was a new buyer, I'd be worried about the 8 billion share hammer that is hovering over the head of this stock. For the sake of all investors, I hope I am very wrong.