bioman:
You imply they will wait with top line data until they finish the NDA.
IMO impossible. They need to tease out "everything" they can from the data before even asking for a pre-NDA meeting with the FDA.
It will be ~5-6 months from topline data to filing the NDA.
The co. had said in 2012 "by the end of the year" until the Sept DMC meeting when it was changed to "in January." Mgmt recently responded to a question (Siavoche) and confirmed "in January" so I assume the DMC meeting is scheduled. So I do not expect any particular timing, and it could well fall into Feb by a couple days. (If a snowstorm occurs shutting down transportation right around whenever the DMC was suppose to meet, they'll simply wait a couple weeks.)
If its tomorrow, great, if not then it'll be later. But I am not playing with the Jan13 options so I have no dog in that fight.
GLTA, sincerely hope we do get news soon. As I memed on twitter, #HEATexhaustion. :-)
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