Response in November?
Admittedly impatient to learn about the FDA's decision re NT-pro BNP, I recently called the company for info. It turns out that there indeed have been some amendments and delays to the application. But it may be a good thing in the long run. In august Response submitted additional info which may substantiate the claim that the pro-BNP test is in some ways SUPERIOR rather than equivalent to existing tests. That would be a big deal, IMO, and worth the additional wait. So, the 90 day clock restarted ticking in Aug. But a decision is not necessarily expected by Nov. because the 90 day figure is just a guideline, not an FDA mandate. I expect the next few months to be more than interesting for Response. The 3M flu test may get approval during this flu season (early 2008?) as well.
Patiently,
Urche