RE:RE:RE:RE:NewsBIT1 wrote: What we need to know from the NR.
"To gain Fast Track designation when there are existing available therapies, a potential new therapy must show an advantage over other currently available treatments, such as showing superior efficacy, an improved side effect profile, decreasing toxicity or ability to address an unmet medical need."
This caught my eye also, the FDA knows the current 2 drugs on the market for IPF are not performing and IPF patients quickly need something better.
Also:
Fast Track designation drugs are also eligible for an accelerated approval and priority review, thereby expediting the FDA's review process