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Biotech / Medical : Provectus Pharmaceuticals Inc.
PVCT 0.06400.0%Nov 7 3:22 PM EST
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To: pincus who wrote (12657)1/24/2014 1:17:17 PM
From: pincus   of 13111
 
Feuerstein responding today to PVCT's objections:

Moffitt is conducting a follow-on study of PV-10 in melanoma patients, but in the year the study has been open for enrollment, Moffitt has managed to recruit only nine of a planned 15 patients, according to Moffitt study coordinator Erica Royster. I spoke with Royster on the phone earlier this morning.

This Moffitt study is designed to assess immunological and blood biomarkers of melanoma lesions injected with PV-10 and will not measure tumor response, progression-free survival or overall survival of the patients enrolled, Royster told me. Moffitt refers to the trial as a " feasibility study." In other words, Provectus will be unable to use this Moffitt study to further demonstrate the efficacy and safety of PV-10 in melanoma patients. Again, FDA doesn't base cancer drug approvals based on immunological response data, particularly from a tiny 15-patient, single center study. [That is, assuming Moffitt can actually complete the study. Enrolling only nine of 15 patients in a year isn't promising.] (end of quote--there's plenty more on his blog)

Given the very disappointing nature of the latest release and the rather indifferent approach Moffitt seems to have, PVCT has a lot to answer for.
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