Cramer said in his Off the Charts segment last night to buy GIVN after earnings in a few days. I have owned GIVN a long time,and it is precisely the same fundamental reasons Cramer talked about. It has been a slow rise, but it has been working. FDA approval is bound to come,and patient love for the PillCam over the alternative is already clear.
The only reason, IMHO, price didn't rise today on news of 2 new products is because Cramer inferred that the price would come down with earnings report, that it wouldn't be blockbuster. Perhaps he doesn't know that the current price is cheap as hell, down after the 8% sell-off from profit-taking after a long and satisfying run up.
New software is touch-screen or can be adapted by existing customers and is more user-friendly.
Anyone know details of application for FDA approval? Haven't seen this on board. Has there been an application?
I searched the other day for anything referring to the PMA in their news history. Nothing about filing yet but that they think they will do that by early 2011 and be selling in US by 3rd Q or so....just running on memory, so not 100% accurate here....but I believe I have the year right. This shouldn't be a terribly difficult PMA from a clinical standpoint because, although you swallow the pillcam, the intestinal system is considered external to the body (think about it and you'll see). My experience is that this sort of PMA should be pretty straight forward as long as it's done right. THeir biggest challenge or concern will just be getting the software qualified sufficiently to meet FDA standards (IF THEY havne't already). Good company IMO.