jq1234,
According to my sources, the European regulatory authorities recommended a filing before ECYT presented them with the new data. So there must be something, even in the original data, that the European authorities liked.
Furthermore, the FDA has allowed ECYT to import Doxil from Europe, so the PROCEED trial can continue without interruption--data due in early 2014--and it means that ECYT doesn't have to use Lipidox, which might have screwed up the trial. It has been reported that the FDA has provided ECYT with a written agreement that one trial will suffice using PFS as the primary endpoint.
Also, ECYT will begin a Phase II trial in lung cancer this quarter with PFS as an endpoint and data expected in early 2014.
After today's announcement the cash position is very strong. With around a $280 million market cap and $220 million in cash and MRK picking up some of the trial costs as well as expanding into other cancer indications, this still seems undervalued to me, even after today's run-up.
I value your opinion, so I'd like to get more of your thoughts on ECYT.
Bladerunner
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