Biotech Values

[croumagnon]

An NFLD Fast Track Fiasco Or...

The FDA was expected to respond to NFLD by Today concerning their application for fast track designation for Polyheme. The response that was disseminated today was a bit puzzling:

http://biz.yahoo.com/bw/061010/20061010006348.html?.v=1

In particular: "Northfield submitted an application for Fast Track designation for PolyHeme in August. Fast Track does not apply to a product alone, but to a combination of the product and a specific indication for use. Northfield's pivotal Phase III trial is atypical in that it has dual primary endpoints of superiority and non-inferiority. The breadth of the label indication Northfield intends to seek for PolyHeme will thus be dependent upon the outcome of the pivotal trial. Therefore, Northfield and FDA have agreed that the decision will be deferred until the endpoint which will be the basis of the Fast Track designation has been determined."

I find this to be a strange response that either indicates that NFLD does not have a good handle on FDA procedures (Bad?) or that some new info is making NFLD believe that superiority is a lot more possible than previously thought and, therefore, they are seeking to expand the label with the fast track designation process...

Any ideas or comments?