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Biotech / Medical : Provectus Pharmaceuticals Inc. -- Ignore unavailable to you. Want to Upgrade?

To: LT2011 who wrote (11366)	6/26/2012 7:31:21 AM
From: NTTG	2 Recommendations Read Replies (1) \| Respond to of 13111

Two years to lock the database...amazingly slow for 80 patients. Gotta wonder what took so long, particularly because the data doesn't look that different in the end. They finally got away from trying to compare responder and non-responder PFS, that is a good thing.... But the rest of the two year in waiting data is the same as we have seen before: The CR + PR réponse rates for stage III (58% and IV (22%) are in line with previous (apparently now considered incomplete data presentations). Only 3 stage IV patients showed a PR or CR; proposed PIII will be limited to PIIIb/c patients, no stage IV (still vague on how many lesions can be injected but with a 12 week response assessment it doesn't look like there will only be one re-treatment opportunity; 61/80 patient in the PII got 2 courses, wonder which ones they were). Again...those are respond rates for the target lesions, the lesions that got a 50% (by volume) injection of a directly cytotoxic agent. Since their is no comparator arm I am not sure what inclusion of SD really means, and the FDA did not accept loco regional control as a primary end point. With a cumulative dose range of 0.3 to 26 ml injected you would think they could calculate a 'bystander effect vs dose' graph to confirm that the bystander effect is not simply due to drug leaking into systemic circulation. Such a simple calculation, why so timid on this point. Would be nice to know which bystander effects are visceral mets vs local non-injected lesions. no new mouse data, Moffitt was a one and done? Now they indicate PIIb for MOA in patients will commence summer of 2012. Interesting that they will only inject one lesion for patient immunology study.....only 35/80 patients in PII received only 1 course of therapy...I wonder which ones they are in the data set? PIII trial will start in late 2012 too..lots of new $ will be running out the door shortly Clear to see why SP didn't budge after this presentation; old images, old story, no new analytics after 2 years of data scrub and analysis. Vision for this application is more narrow (appropriately so) than was discussed after the 2012 ASCO presentation