Talon Therapeutics Inc (fka TLON)

[tape660]

I'm concerned about this from the 10-k
http://files.shareholder.com/downloa...4-11-17382.pdf

Based on the data from the rALLy study, in the first half of 2011, we plan to submit to the FDA a New Drug Application, or NDA, seeking
accelerated approval of Marqibo in Ph- adult ALL, in second or greater relapse or that has progressed following two or more prior lines of antileukemia
therapy. At a February 8, 2011 meeting of the FDA’s Oncology Drug Advisory Committee, or ODAC, the FDA indicated that a drug
sponsor and the FDA must agree on the feasibility and design of Phase 3 confirmatory studies as a necessary element in the NDA submission process for those sponsors seeking accelerated approval. According to the FDA, a sponsor seeking accelerated approval should not submit its NDA until such agreement on Phase 3 confirmatory studies has been finalized. Our NDA submission may be delayed if the FDA does not
accept our proposed confirmatory Phase 3 study.In addition, we are conducting a Phase 2 study to assess the efficacy of Marqibo in patients with metastatic malignant uveal melanoma as determined by Disease Control Rate (CR, partial response or durable stable disease). Secondary objectives are to assess the safety and antitumor activity of Marqibo as determined by response rate, progression free survival and overall survival. In addition, patients undergo continuous electrocardiographic evaluation during the first dose of Marqibo exposure. The patient population is defined as adults with uveal melanoma and confirmed metastatic disease that is untreated. We have enrolled 49 subjects to date and plan to enroll up to a total of approximately 59 subjects in this clinical trial.

So what does this mean?
They want a confirmatory phase 3 trial. From the looks of the situation, TLON is going to seek approval with phase 2 data. What the FDA wants is, prior to any accelerated approval with the limited info, a phase 3 trial design spelled out for them so that IF they approve marqibo, TLON will have to follow up with their phase 3 to maintain the approval. In this sense, patients can get marqibo as a last ditch effort for their cancer until more data comes out. If marqibo falters in the phase 3 trial it's probable that the FDA will revoke approval.