Post by
RetailRube on Aug 28, 2015 12:03pm
I think they got Priority Review
They must have heard something from the FDA, to justify a halt. They would have had to wait until the end of today to say "We didn't hear by Day 60 and so we are now only elegible for Standard Review." Therefore they must have gotten Priority Review. And you don't get Priority Review if you get an RTF. Therefore, I think we are on a runway that ends in February 2016. But as always, I could be wrong.
Comment by
DryBones on Aug 28, 2015 12:10pm
we can speculate, but it is also possible it was rejected, in which case we wont hear until after the market closes. GLTA
Comment by
RetailRube on Aug 28, 2015 12:13pm
Killjoy. That's an RTF. Why reject on Day 60? Why not Day 14 when they schedule the meeting with the FDA Division Director, per their procedure manual?
Comment by
loveshackdave on Aug 28, 2015 12:17pm
Why would they issue a halt if they were going to wait until market close?
Comment by
RetailRube on Aug 28, 2015 12:21pm
In case there is a leak, such as in the Press Release organization, or maybe their e-mail system has been hacked and an outsider has already read their e-mail. Officially or Unofficially.