basically it states that HUD decision was due by now and that in 2012 FDA was not late one time responding to HUD. Good news, HUD was not rejected, meaning that at some point during the last 46 days, the FDA requested more info from NVIV. So we just don't know a new time frame until NVIV divulges some info to us. This is all imo based on what I believe to be accurate posts by other posters, do your own dd. I will continue holding and will buy more if it stays around $2 or less.
Alabama, from what I'm able to gather, this is all true. The HUD will take longer than I expected to get approved, but in no way did the PR say it would get approved by now. "Feedback" from the FDA by end of January isn't the same as "Approval" by end of January. This is a buying opportunity for those wanting more shares. My guess is the company hears back from the FDA sometime in March or April. Hopefully, at that time, it'll be approval. Also, the trial protocol will not be approved until Humanitarian Use Designation and the corresponding HDE has been decided. Trials may not start until middle of the year. That being said, when the green flag is given, the PPS will be considerably higher than it is now.
well we know the HUD filing date, we know the FDA timeframe, we know last years FDA on-time record. We know a rejection has not been announced and the company could not withhold that info. So there's really not much to guess about, except when did the 45 day clock restart? all imo, do your own dd