Well the FDA have already seen 95% of the BLA twice before right!
So while it still takes time compile the new data into the BLA, the FDA should only be looking at the new 5% data elements.
I do say should…but it is a government agency which is highly process driven and highly risk adverse …let’s hope the new FDA management keep up their proactive stance of cell and gene therapies being tabled and state the 2 months review.
Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-166
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