I think that Talon not being able to have a patient enrolled in their Phase 3 trial was one of the main reasons for a non-priority review. The priority review would have put a PUFDA date in Mid-January, which would have not giving enough to start the Phase 3 trial. Giving how important this is to the FDA, especially after the Feb. 9th ODAC meeting, when the FDA stressed the importance of companies needing to honor their commitment to following through on a Phase 3 trial after accelerated approval, I think that Talon either withdrew their request for Priority Review or the FDA advised against with the main reason being that their Phase 3 TRIAL would not have started at the time. I think that if you look at their Corporate presentations from the past they always harped on priority review even giving specific dates for accelerate approval of 1st quarter 2012. I think that the FDA is trying to set a precedent with making sure companies began their Phase 3 trials. By May Talon should have patients enrolled and maybe even a first batch of results which would only strengthen their case for approval. I think the non-priority review was not based on the drug itself but rather a decision to give Talon the best chance of approval which would be bolstered by the Phase 3 trial initiation.
Talon makes a point to reference this yesterday's PR.
"We aim to initiate and commence enrollment in the Phase 3 confirmatory trial, that recently received an SPA, prior to the May PDUFA date," Dr. Deitcher added.
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