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Posted On: 07/12/2019 1:14:01 PM
Post# of 148988
With regards to why do we not submit part 3 of the combo BLA while we wait for safety data.
I’m not positive, but my background includes writing parts to these CMC filings which include both Drug Substance (the AFI) and Drug Product (final formulation) sections. My thinking is that if we do not know the final dose, 700 or 500mg, we cannot complete the drug product section.
I’m not positive, but my background includes writing parts to these CMC filings which include both Drug Substance (the AFI) and Drug Product (final formulation) sections. My thinking is that if we do not know the final dose, 700 or 500mg, we cannot complete the drug product section.
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