Talon Therapeutics Inc (fka TLON)

[onkelhubert]

The point is Talon never requested for priority review.

"A request for Priority Review must be made by the drug company. It does not affect the length of the clinical trial period. FDA determines within 45 days of the drug company’s request whether a Priority or Standard Review designation will be assigned."

Fast track status and accelerated review both don't really affect the timeline of being reviewed by the FDA.

www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm

So, Talon never told us that they are asking for a 6-month timeframe for a PDUFA date after submission. They always taked about fast track status and accelerated approval but they never lost a word about priority review.

many took that for granted...