For those that don't think we are still talking to OTATSo in the...

For those that don't think we are still talking to OTAT


So in the possibility that there has been a delay, could it be due to the FDA not meeting a expected time frame for the minutes to be returned from a type C meeting?

We would have required a type C meeting to discuss the proposed potency assay and to set the parameters of that test. This is likely the last hurdle before resubmisson . Not a straight forward process though as the FDA would need to accept the potency assay before setting the parameters . Those minutes may not even be late or perhaps they them selves have raised further need for discussion .

With news of the BLA been filed we can be reasonably sure that OTAT have agreed with the potency assay and the data is satisfactory. That I believe was the biggest hurdler of the CRL , the review process is well underway.

Good luck all.