Replies to post #13954 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>...since the facilities have already been inspected (as I recall); and since GTCB was submitting an accelerated rolling BLA; then it is not inconceivable that approval may occur much sooner than February, perhaps even in 2008 :).<

FDA approval of ATryn in 2008 is very, very unlikely, IMO. The FDA rarely acts sooner than a few days prior to the PDUFA date. When the drug is not a new molecular entity for a life-threatening condition, such an early decision is ever rarer.