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Biotech / Medical : Provectus Pharmaceuticals Inc.
PVCT 0.06490.0%11:38 AM EST

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To: boomertree2 who wrote (12057)6/11/2013 9:39:59 AM
From: NTTG1 Recommendation

Recommended By
Pogeu Mahone

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It is highly unlikely that nodal stage III or stage IV patients will be included in the finalized PV-10 PIII protocol (unless a third combination Tx arm is included), that is a matter of public record. Dosing is critical and I suspect the reason more aggressive disease patients are not going to be allowed is their poor response in PII trial, and reluctance of the FDA to allow increased dosing in PIII.

Why would more tumors need to be injected to achieve an immune response, very counter-intuitive to basic immunology principles of primary immune response and boosting processes, see Vical protocols for true immune study design in stage III and IV patients....when PVCT talks about injecting the maximum number of tumors, they are drawing attention to the cytotoxic aspects of PV-10 to achieve PFS outcomes, not an immune mediated therapy approach.

Most of the white paper focuses on 'unpublished(able?)' observations, not even close to the PII data sets EISAI is producing, or the PD-1 and 2 immune modulators are cranking out

But I do understand your excitement, from a PR perspective
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