Data is solid, biotechs that I trade that get extensions generaly mean that FDA wants to firm up the label and/or REMS with the company before they aprove their drug, or it's because they weren't able to schedule an adcom before PDUFA. Raptor hasn't had an adcom meeting scheduled yet I don't know if the FDA plans on having one but if they do thats why they extended.
What the hell are you talking about? It is other way round. Out of 10, 9 were approved with extension. Please name one which one was not approved with extension except pgnx (is it?). Alxa was not approved with extension b/c they change the dosing by themselves, actually they had manufacturing issues. So, please perform some research before comment on something.
I fully agree ... this is a simple delay, not a rejection.
The fact that additional studies are "NOT" asked is an excellent sign.
Probably additional paperwork, fiscal cliff, staff change in FDA had something to do with it.
This is an excellent company at a very cheap price.
This long is convinced there is nothing to be concerned about.