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Biotech / Medical : Provectus Pharmaceuticals Inc.
PVCT 0.0650+0.2%Nov 18 12:36 PM EST
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To: Howard Williams who wrote (11959)5/22/2013 10:19:40 AM
From: boomertree2  Read Replies (3) of 13111
 
Good article. However, I was disappointed in Argarwala's response regarding pv-10 bystander effect on distant tumors: "Right now we consider such a response to be a bonus clinically, and it is not something that the phase III trials will investigate." A material part of pv-10's value is its ability to treat distant tumors other than those directly injected. If the bystander effect is not going to be part of the phase III trial investigation, then we are left with a trial focus on treatment efficacy on injected tumors. Query whether this has been the cause of the delay in the the negotiations between the Company and the FDA to finalize the treatment protocol design of the Phase III trial.....Provectus wanting a trial design addressing distant tumor treatment efficacy, and the FDA limiting the design to locoregional disease control of injected tumors. Could also explain all the Provectus recent activity with Moffitt to substantiate the bystander effect in an effort to influence the phase III trial design. If Argarwala's comment is correct, then Provectus has failed to broaden the scope of the phase III trial design, and we are left with injected tumor disease control. Let's hope the Argarwala comment is not correct.
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