found this in investorshub
received call back finally from investor relations
1) will send out something when get official determination;
2) ongoing discussions with fda
3) did not say expressly whether fda asked for more time or not (tried to press this issue);
4) does not think any issue with treatment as device (and fda has not raised this issue)
5) confirmed hud filing on dec 14
6) can clearly show device to serve population of less than 4000 for HUD
7) be patient
Obviously, the stock is tanking due to lack of information
i am holding my positions and praying!!
i remain cautiously optimistic, and hope we get positive information and soon!
good luck to all!!