this is not good news on any level. we already knew we had a clear path forward. this is on the more difficult and risky end of those options. There will be time to set up the studies, time to perform, time to collect the data, time to put together resubmission, time for the review. All in all, this is yet another yearish delay if not longer. The FDA drives me crazy. All we have to look forward to are surprises that may come along in the meantime from all the coals we have in the fire.
from the FDA:
Comparability Bridging Study: A study performed to provide nonclinical or clinical data that
allows extrapolation of the existing data from the drug product produced by the current process
to the drug product from the changed process.
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