The following message was updated on 7/23/2021 9:48:00 PM.
So, for those of you know about assays and the process of development - how difficult is it?
So, still absolutely dumbfounded as to why this keeps dragging out with ZERO completed submissions for EUA. I am curious, how difficult is it to develop a proper functional assay and complete CMC package? what are the chances that Novavax is unable to complete this part of the process? what are the chances they hit a wall and just can't figure out how get through to the next step in the process? It seems to me that the assay should be an easy task for these guys. About the CMC package, how long would this normally take? I am well aware that outside of the pandemic these things usually move at a tortoise pace and drag out for years and years (and years), but still to this date I am trying to understand why this is all taking Novavax so much longer than the competition. Maybe I am beating a dead horse here. What else is there to talk about? Maybe they will give us something better to talk about next week? Not looking forward to next Friday if there are no formal submissions.