Scroll to the end to find a normal 510K clearance expectation of 90 days for substantially equivalent (SE) devices. The J-Plasma is SE to the ARGON devices granted under the FDA classification code GEI.
Here's a link to Valley Labs 510K GEI Classification ARGON device:
As you can see, the J-Plasma does the same things as the already cleared GEI Classification ARGON device––only the J-Plasma does these things with lower energy levels, superior adjustability and lower spurious patient currents (According to Konesky's patent claims.
However, the J-Plasma does quite a bit more in that an ARRAY of plasma jets distributed through a 2X4" area applicator was discussed in Greg's recent scientific presentation in San Antonio, Texas. His talk was recorded and he used the term "Scrub Brush" to describe the J-Plasma. He also described dermatology as the "Low hanging fruit" for the initial market target.
(1) we have a normal expectation of 90 days for an SE 510K application
(2) the J-Plasma clearly appears to convey SE status with already approved GEI ARGON devices and
(3) there are significant advantages to the J-Plasma device that do not require clinical trials because this is a Class !! device with SE to ARGON.
+++++++++++++ Recent Seeking Alpha articles suggesting six more months of 510K waiting for J-Plasma are not consistent with past BVX (GEI Classification) applications nor are these time estimates consistent with the FDA's own 510K guidelines NOR are they consistent with the substantial equivalence appearance with ARGON devices of the J-Plasma.
This surprise article was at best misleading––Perhaps intentionally so.
Dragan,I have been mulling the same hypothesis, Volkswagen/Porche springs to mind.Although I have to admit to being fully freaked out by the insider selling,do you think that it could have a part to play in such a 'theoretical' deal?
One. MM is playing games....I would suggest everyone should removed any stop-loss orders that might be placed. As Kag said, place low bid buy orders in escalating amount, like 500 at 6.65, 1000 at 6.45, 3000 at 6.25, and so on....
Two. What about VERY speculative possibility, but not that crazy one. Let's say the future partner is actually having a plan for buyout, instead of partnership. So, they are only waiting for J approval. What would they do ? Accumulate some shares through third party, and keep selling ( "dumping" ) to keep share place artificially low, and make buyout price low. Ya, this is illegal, but we know has been done many times, and SEC can not do anything...
Oh, yes, I am doing my part of playing games with MM.....
After call, great day for day trading.... "Watching" SVNT, IGC, and GS options...