(Total Views: 488)
Posted On: 02/19/2021 11:23:31 AM
Post# of 154091
Quote:
But comments by NP dating back to the summer such as why the BLA got rejected ( saying it was only a syringe issue) turned out to be absolutely false .
That is false. He mentioned two issues. The FDA wanted the syringe manufacturer named in the report, but it was already listed in two locations. The other was that they wanted additional data from the just completed monotherapy trial which of course was not even available at the time of the BLA submission.
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