As I remember, I thought the company expected to release some news about hydrogel before the end of this year?? And I know they expect FDA approval to start human trials in Q1. I plan to double or triple my position here after the AMRN saga is concluded. They should get NCE news any day and then a buyout shortly after. I would love to pick up more NVIV at this 1.60+/- level
As I recall they had submitted to the FDA an outline of a Phase I program with hydrogel in peripheral nervous system and were waiting for the inevitable suggestions from the FDA on how they want it changed.
Then NVIV resubmits based on suggested changes and probably gets it back with more suggestions.
Eventually NVIV will submit a program in great detail for the FDA to ok for a Phase I trial.
Even though the submittal has been reviewed and tailored to the FDA's requirements it almost seems like they then treat it as new to them and then goes through a thorough review.
This has been going on for number of months so maybe we'll hear something this spring.
I may be confusing this with the spinal hydrogel program but I suspect we won't get anything from FDA on it until the scaffold program is given go ahead for Phase I.