MSB Trading 2021 - paradigm shift, page-10020

This is what the OTAT meeting is meant to resolve
Those issues were distributed before the ADCOM meeting but the panel was only asked to vote on efficay and safety which came out 9-1 in favour of recommending the FDA approve the product on the safety and efficacy basis The CRL was issued which the OTAT will then resolve the issue and the culmination will be either proceed to the FDA for a BLA or go back to the drawing board
At the moment MSB has spent about US$10 million resolving assay tests to guarantee homogeneity and heterogeneity of their samples and they also have in vitro proof that their theories work plus they have bio-markers which determine which patients the product will work best on
We are all on the edge of our seats waiting for the OTAT minutes which will then guide our next steps in this process