0) From a clinical perspective this is data we are generating on an on going basis. Analytically this is a largely a function of the characteristics of the affinity, specificity of the capture molecule used to capture the target (viral particle). As you point out EUA gives opportunities to launch sooner... But it's still critical to validate technogies both internally and externally probably to a greater extent than the de minimus EUA reqs
1) great question. Our approach is novel which allows us to tap into new supply chains that are inherently more scalable (think semi-conductor Fab) but the trade off is execution risk.