3 ms·
A fair point, but with the FDA responses taking up to 30 days you burn a lot of runway.
by seidleroni 4y ago
A fair point, but with the FDA responses taking up to 30 days you burn a lot of runway.
- ska 4y agoThey have a 180 day review commitment. A 30 day delay on their side would be unusual and burn a big chunk of that clock.
- s1artibartfast 4y agoThat's why you have several Type B or Type C meetings during development to work out the kinks before you submit a protocol.