June 26, 2012

2nd European Post-Chicago Melanoma Meeting 2012 (more)

My summary conclusions from, among other things, Dr. Agarwala's presentation, management's presence at the Munich conference, data analysis, further information gathering and due diligence:
  • Provide a patient enough PV-10, whether through more re-treatments or delivering more drug in general, and MM (cancer) goes away;
  • The trial did not sufficiently positively impact several patients because the limited treatment regimen, by trial design, handcuffed PV-10;
  • The implication (of the two points above) is that doctors should/must/will try PV-10 first, before either surgery or another non-surgical therapy, to illicit an efficacious result for the patient before determining what other treatment option to utilize;
  • There is a clear systemic benefit;
  • Overall disease burden is reduced;
  • PV-10's response is durable;
  • The FDA is helping to get the drug approved; and
  • For FDA regulatory purposes only, PV-10 will be used for Stage 3 disease. As soon as PV-10 is approved, the drug will be used for Stage 2 and Stage 4 disease.

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