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TLON..$.93 Key information from their 2010 ASCO presentation from their RALLY study. The data is far from "underwhelming" and is very impressive. This is in 3rd-6th line patients who had already been on regular vincristine. The results are significant in a disease with few options. This is why the FDA granted "accelerated approval." Accelerated meaning conditional approval with Phase II instead of Phase III data and not standard review to priority review. Priority review meant nothing to Talon if they could not get the confirmatory studies up and running in time. The extra 4 months (standard review) has given them time to get their studies in place. Still waiting on a pt to be enrolled in the HALLMARQ conf Phase III study. Standard review was best for Talon.

The FDA also gave them a SPA for their confirmatory Phase III study understanding that if they approved them on single trial Phase II data that the company would have sufficient time to demonstrate that their durable response would translate into a meaningful clinical benefit (i.e. increased survival advantage). This was the 56 pt study as the data has been updated to include the 65 pt study as well. Still solid data.