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Re: bmatt post# 5674

Wednesday, 06/19/2013 2:24:18 PM

Wednesday, June 19, 2013 2:24:18 PM

Post# of 6072
My answer from Talon:

"I refer you to the January 2013 press release stating that Talon had engaged Goldman Sachs to pursue strategic alternatives. Also, we are in compliance with all FDA requests.
Regards,
Craig"

My Question:

Marqibo received an accelerated approval for adults with Philadelphia chromosome (Ph) negative acute lymphoblastic leukemia (ALL) in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy on august 9, 2012.

Here it is close to one year later and the product has not been launched. Isn't there a time limit that FDA would put on how long Talon can wait to launch a new drug after receiving an accelerated approval? Also there was a deliverable in June to FDA regarding making the Marqibo drug easier to prepare and FDA wanted to know how Doctors were doing in the prep, to date.

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