So you're saying that "This Time" you believe they'll meet the timeline....but last time you didn't. When you flip the coin is it heads they'll meet it and tails they won't....or the other way round.
Sorry for my demeanour.....missing timelines bugs me. If you make a public commitment, and you're not going to meet it....don't just, "ho hum...we'll have it by the end of NEXT quarter". Be proactive and put something out that says...."While we had previously committed to providing an orphan indication by June 30th....blah blah blah, whatever the reasons or rationale are".