RestlessMaybe you're right, very hard to say. FDA returned serve...

Restless

Maybe you're right, very hard to say. FDA returned serve with a few questions(quite a few?). Some of them might be time consuming to gather evidence. No idea how much Race was relying on old documents for proof or whether FDA standards have changed in the years since. But yes, they might be forced to abandon their application if they cannot provide a satisfactory reply and I guess that counts as a wipeout.

Does anyone know that Race is still working on their reply? No reply from Race to my question - about 10 days and counting.

Cheers