(Total Views: 371)
Posted On: 07/16/2021 10:36:08 AM
Post# of 151766
Would I be wrong in thinking that if we get the thumbs up for the dose justification with receptor occupancy submission then it should be clear sailing from there and onward to a BLA acceptance and PDUFA date?
Even if there were an issue, holding up the approval process for a RO test seems irrational to me and is something that could easily be done with a phase 4 type study post-approval but what do I know.
Even if there were an issue, holding up the approval process for a RO test seems irrational to me and is something that could easily be done with a phase 4 type study post-approval but what do I know.


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