(Total Views: 799)
Posted On: 09/26/2020 1:27:58 AM
Post# of 154813
Quote:
a misstep with the BLA with HIV
Where a misstep may lie is not insisting on submitting at the 525mg dose back in February 2019. Of course the FDA might have went into a snit and refused to accept that BLA. Subsequent to that it's all been on the FDA. First demanding the 700mg dose, then requiring additional safety data from the mono trial. Once that was done requiring all other data from the mono trial. BLA was submitted and ready to roll then they want the rest of the data from the mono trial which hadn't even been finished when the BLA was submitted. No, the hypo kit was no real issue because it was already in the BLA.
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