Otat update out as Si predicted. The good news is I think we can rule out Annihilation. MSB is clearly making progress with the FDA, and I think they are trying to ensure the FDA specialists agree with absolutely everything prior to the BLA resubmission. I dont think shareholders can ask for more than that.
It seems now that MSB is trying to get OTAT to say that the data / evidence to support your new quality attribute being relevant is reasonable. That is where the failed trials will come in, since as with the tnfr1 levels correlating to efficacy, this new assay will likely show the same thing in the treated arm where lower levels correlate to worse outcomes and vice versa. I guess their argument will be if CMC is reasonable, if potency assay and CQA are reasonable, if the last trials backs up the CQA and efficacy, if you hit the primary end point..... why would they need another trial? They might use data generated from the ARDS trial also.
MSB to submit this data that is allready generated
... I think bla resubmission is still on for 2022.
Happy new year!
Merry X-mass, Happy new year & Standby for Blast off or annihilation!, page-34
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