Thanks for the summary.
"New data submission will be evaluated as part of resubmission, so next step is resubmission. No additional OTAT meeting requried prior to resubmission."
SI was a bit cagey, on this question about OTAT, but I think it may be that SI wants some re-assurance with OTAT prior to the BLA resubmission for Ryoncil.
Otherwise, if they have the OTAT data already and most of the original BLA documentation can be re-used, why is it taking so long to resubmit the BLA?
Overall - I was quite disappointed with the call - as it means, you've guessed it... More waiting!!!
But, SI did let it slip that they are still working with NIH and the FDA on C19 ARDS
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