Malcolm:
I think you have got a good point there. But, still I would like to
add, based on my previous experience, that:
1. You can get a written consent from the FDA for biowaiver prior to
your ANDA submission. They would not back out once something has been
committed.
2. At the end of day, getting a biowaiver or not is very much
dependent on your f2 value (= or >50) by dissolution curve
comparisons and at Level A correlation through pilot BE studies.
Ed
UBI
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