Once published, the study will be used in our approved international markets to support our distributors and LuViva's expanding product launch." Does this indicate that the company already knows the outcome of the
Luviva is ALREADY approved in Europe, Canada...... So yes they know the results of the study. We are just going thru the motions with the FDA. Last submission they had 3 questions holding the approval. I expect FDA approval this summer. A new submission to the FDA should be completed this quarter. FDA is always a wild card.... but Luviva is basically approved worldwide but somehow we are still waiting for FDA green light.
Same is going on here with luviva as it is with the HIFU system for localized prostate cancer treatment (edap), when the FDA approves both innovative procedures ...........make your calculated bets. For that matter navidea (navb) is bringing along advanced cancer diagnosis testing just ok'd
by the FDA. High technology is slowly but surely entering into the bio market.
Sea, I am surprised by the muted response by Mr. Market today. However, I am hoping/expecting a test of 62 cents later this week. Hopefully we can start building some traction and awareness. Bottom line the big move is not likely to occur prior to FDA approval sometime this summer.