While the bashers will not allow contrary facts to change their negative thesis, it makes sense that shareholders and prospective shareholders consider FDA actions in comparable situations in forming an opinion of the likely course of PV-10 to ultimate approval and commercialization. Here is one situation where the data are arguably weaker than that for PV-10 and the FDA has approved the drug.
Note that this drug was approved based upon Phase I/ IIb trial of less than 50 patients (as opposed to PV-10 Phase II with 80 patients).
It was a single arm trial, like that for PV-10.
Overall response rate with just shy of 59%, which is lower than PV-10's for treated tumors and patients where all tumors were treated.
And, unlike the relatively safety of PV=10, some of the side effects were quite serious: hemorrhage, infections, myelosuppression, renal toxicity, second primary malignancies and embryo-fetal toxicity.
For the full details, click here.
Disclosure: I am long PVCT.