The huge sell-off and continuing downturn for GIVN should have been a big RED FLAG. The numbers were disappointing, and even worse, plans to submit the PillCam to the FDA, which is what brought most of us to GIVN in the first place, are very tentative:
"The Company plans to submit this product for FDA clearance in the fourth quarter of this year, following a meeting it plans to have with the FDA in the near future. Feedback from FDA may impact our planned submission."
That last line is another big red flag. If the feedback isn't good, how much longer will we have to wait until GIVN finally submits the product?
Looks like this could be dead money for a long time, but patience (a LOT of it) could pay off in the end. Are any longs still out there?
If Catch-cap and Capso Vision introduce their Colon Capsule in 2016 in USA,will they be infringing upon Given Imaging patents? Will Given Imaging try to STOP them? This is an important question as with 3 companies in Colon Capsule market in USA versus only one makes lot of difference in price and therefore market share? Does anyone have thoughts or comments?
Don't think it's a "big red flag." Don't think the timing will deviate much, if at all. They must say that their submission timing is contingent on a preliminary meeting, but this only ensures that, once the submission is made, the likelihood is that GIVN will have supplied what is necessary and all will be satisfactory.