Provention Bio Resubmitting Biologics License Application for Delay of Clinical Type 1 Diabetes in At-Risk Individuals Following Type B Meeting with the FDA
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Thursday, January 27, 2022
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In preliminary meeting comments,the FDA noted that the data package presented does not adequately support PK comparability because predicted primary PK parameters are indicative of a lower exposure.
Key Points:
- In preliminary meeting comments,the FDA noted that the data package presented does not adequately support PK comparability because predicted primary PK parameters are indicative of a lower exposure.
- The Company believes it will be in a position to resubmit the BLA in the first quarter.
- We look forward to re-submitting the BLA as soon as possible and facilitating the FDA's review and decision-making.
- As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products.