Avid Bioservices Inc (CDMO)

[spacey]

No, IMHO FDA will not say start over. With cleared or with the speculatively positive data, or partial data, they can go directly into phase 3. It is the approval of the protocal for (trial design)by FDA that will ultimately meet the FDA requirements, for reaching a final dataset usable after the phase 3 that can be used for drug approval. That data set with all the safety/ side effects issues is all they will need from FDA in the end with approval of manufacturing facilities, which we already have but will need to expand because BAVI is a MULTIBILLION DOLLAR DRUG. Phase 2 data if not good,or at least a good salvagable subset, then it would be stupid to even think or plan a phase3 for NSCLC. If data not good, didnt smell good, or look very promising, they wouldnt even approach FDA for a phase 3 because it would be a waste of time and money.