Bryan,
Here's the scoop if FDA question regarding RATCOM:
The procedure for securing FDA approval on some new gizmo starts with having your new machine on test at a number of institutions who each have an internal review board (IRB) looking at the efficacy of the machine and the results it produces. This allows a new gizmo to be used for the benefit and best interests of the patients involved.
Once these tests are completed, you then file for a pre-market approval (PMA) with the FDA. If the FDA already has approved another gizmo which accomplishes the same thing in the same way, the only way to get your machine approved is by filing a 510-k with the FDA. This can be done if your gizmo is materially better.
To date, no ploy-d machines have been approved by the FDA. Becton Dickenson, Johnson and Johnson (who may be exiting), Coulter, and RATCOM are all out there doing their IRB's. The reason that RATCOM has the inside track so far is that none of their competitors can reach the 75% threshold in accuracy required to get approval. RATCOM is runningin the 95% area. This is why this would have been a great acquisition for SEXI.
The machines can be sold for (don't hold me to exact numbers) 40-50,000 bucks or given to the institution, whereupon you can receive $75 for each test done. There are over 3000 potential sites that this machine can be installed. Multiple placements in any one institution are very possible, and expected.
Here's the math: If they sold only 3000 machines to any combination of the sites, they could collect $75 X 3000=$225,000 per day if each machine is used only once per day. Most institutions would do more. But even at only one per day, that's $81,000,000 per year in revenues.You guys have chosen not to believe the potential here, and it's a big mistake. This unit is ready to deliver, unlike anything else SEXI has to offer. Pretty good, isn't it? That's $1.25 per share in revenue, with unbelievable margins.
So before you write your next post (and I'm not picking on just you Bryan) on the DNA Analyzer, try to understand that this is the only legitimate technology that SEXI may have had all to themselves. It would be a shame, IMHO, to see SEXI lose these guys. Let's hope that the company has the good sense to be in close contact with these guys in an attempt to keep them under the corporate umbrella. Anything short of this would consitiute management malpractice, no matter who the management is, at present, or future. (it'll change).
Hope you understand, now, why I've liked these guys.
JILTED and ought to have my DNA analyzed |
