Nothing is ever a lock for approval. DCTH had a SPA, fast track designation, orphan drug status, stellar clinical results, EAP, 2 DSMB safety approvals, the NCI was conducting the bulk of the clinical trials, CE Mark and here is the key, they also have a huge short interest like SGEN, result: RTF by the FDA.
We all believed your notion that "Anything else other that outright approval and you will have the medical community, biotech industry, cancer patient advocacy groups, and politicians marching with pitchforks on FDA HQ."
Not a peep from anyone. The shorts are to powerful and have Padzur, politicians, and the FDA in their pocket. The only thing you can guarantee is that nothing is guaranteed.