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Biotech / Medical : Provectus Pharmaceuticals Inc.
PVCT 0.0650+0.2%12:36 PM EST
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Pogeu Mahone
To: Mimbari who wrote (12038)6/10/2013 1:12:42 PM
From: NTTG1 Recommendation  Read Replies (3) of 13111
 
The question was about FDA allowable dosing for the PIII MM trial. The company is on record stating the PII dose design was 'too limiting", so what has the FDA agreed to on dosing...same as PII or something more?

Frankly, your answer would be more appropriate for the HCC trial, since treated surface lesion(s) in the MM trial would be washed off as they die (no systemic necrotic burden as you describe) and the "bystander" effect is slow to develop, no more challenging for the body to handle than the effect of systemic therapy....unless you are suggesting that there is a concern about the amount of RB that is injected into larger tumors given the ~50% systemic absorption and no prior dose response data under controlled conditions?

So again, we are left with no information on maximum dosing per treatment cycle or cumulative dosing constraints, or whether all visible lesions can be treated.
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