In the wee hours of the night, Cell Therapeutics (CTIC) announced that it will meet with the EMEA in September, 2009, for an oral explanation in support of the OPAXIO Marketing Authorization Application (MAA).

Apparently, and this was news to us, there was a previously scheduled June, 2009 meeting with the EMEA on OPAXIO which did not occur due to CTIC focusing all of its efforts on the Pixantrone NDA.

The oral explanation/meeting date with the EMEA now puts a potential approval at 4Q09.

Here was Jim Bianco’s thoughts:

“We are pleased that the EMEA has agreed to an in person oral explanation in September allowing the Company and its lung cancer experts adequate time to prepare a thorough review for the Co-rapporteurs in support of our MAA for OPAXIO in non-small cell lung cancer. The fourth quarter is shaping up to be a pivotal period for the Company.”

Also, over the last three weeks, we have emailed CTIC regarding an OPAXIO update, but have not received a response.

Finally, you can browse through every single CTIC article we’ve ever written right here.

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