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Thursday, September 23, 2021 10:29:20 AM
Additionally I recently proposed somewhat facetiously that Advent could man the lines at CRL/Cognate…..perhaps there could be credence in this?
I have not thought of that, good point. What I personally think is that indeed there is no long-term agreement between CRL/Cognate and Northwest in place at present but this will be negotiated after topline data/journal publication. Its very difficult to determine what is is that CRL needs to be producing if there is not yet knowledge of the data (rGBM for example).
With that agreement, NWBO could submit a request for BLA with the FDA. Im convinced both CRL and Advent are more than prepared to receive the inspection of any RA to accommodate the approval of L. is what I think
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