RE:RE:WHY DO WE HAVE TO WAIT TO SUBMIT IN THE 4th Q??????I was reading quite carefully Fred's reply posted here (part1 and part2).
Got an impression of quite bizzare situation and strange explanations, just doesn't really make sense.
Fred pretty much was saying that company did everything right, no quality or efficasy issues etc whatsoever and then....... FDA came with COMPLETELY UNJUSTIFIED DEMAND.
So there is NON of company faults in this fiasco and all blame must be placed squarely on FDA demanding the ridiculous things? Seriously??? It's strange to say the lease, isn't it???
Then obviously that bizarre issue with such a long delay, while according to Fred's explanaton ALMOST EVERYTHING is ready and on 1 to 10 scale complexity of
this addtitional requirement is 2 (!).
And price for that is almost a YEAR delay and destraction of shareholders value? Doesn't add up at all if you ask me.