I have been long on this stock for some time and am accumulating more with the "dips" in price. Are there any "hints" as to when the FDA will approve the trial (always quoted as being "early Q1 2013). Has the FDA visited the NVIV facility in Cambridge to check on the scaffold production? from the day of approval as noted only 5 patients will be recruited---what would constitute a "positive" result--preservation of bowel/bladder function? return of feeling/mobility if this was originally lost post SCI? do they feel the TIME to recovery in humans will be similar to what they achieved with Rheus monkeys?
If the results are positive--then what? will the FDA require further patients to be treated to render widespread use of the scaffolds in neurotrauma centres? and will a big pharm (?Stryker/Johnson and Johnson) then step forward and buy out the company??