That vote 16-0 is not from FDA....... DCTH will approval any time from now to Sep.
Vol / Avg. 2.81M/3.85M
Mkt cap 43.75M
Sentiment: Strong Buy
True, ODAC is not the FDA. But it was Dr Pazdur on stage doing all the anti-CS arguing. And Dr Pazdur IS the FDA when we are talking oncology drugs.
If the FDA staff was negative (clear from the briefs), and the FDA boss (Dr Pazdur) is very negative, and ODAC is 0-16 then I think the NDA is toast.
It was from FDA!!!What r u talking about?
And they need 18 months of cash
on what basis? they need a new 18 month trial to prove gen 2 works;
ya they do!