They rejected because it was based on Phase 2 data and didn't have the exact metrics. FDA is a stickler for metrics instead of common sense.
I'm sure PVCT has plenty of pictures of folks loaded with lesions and the after PV-10 picture and all the lesions are gone. But that is common sense and logic but the FDA again wants the metrics in writing and scientific format not pictures.
the systemic effect of this drug and wants it approved. They know about the bystander effect along with effects on tumors down stream. Along with NO side effects. Just a couple of hoops to jump through but who knows maybe we will see a bid before we know it.
FDA "Yeah will put in the Label that it can only be used for Melanoma tumors on the skin but the Dr.'s will start using in combination with all the other drugs that are available. " Also FDA went out of their way so the other Drug companies don't get too scared; when they said, " and our inability to determine the clinical significance of the reduction in the size in one to 10 target lesions in patients with locally advanced melanoma, who may have additional untreated cutaneous, subcutaneous, or visceral sites of disease." PVCT "OK FDA like you said back in the minutes in January only for Melanoma confined to the skin."
AF writes about PV-10 being obsolete but the problem is for the Drug Companies that some of their drugs maybe come obsolete or used less.
AF should be brought to task for his one side journalism. AF is making believe that ALL PV-10 can do is shrink tumors and provides NO other benefit that a scalpel can't handle...Maybe Adam should pull up the video of the Old Man who would have had a hacksaw taken to his face if it wasn't for PV-10. Along with the man who would loose part of his arm if it wasn't for PV-10.
Poster Highlights Sessions
Poster Highlights Sessions feature selected abstracts of clinical research in poster format. The posters are grouped by topic and are on display for a specified time with opportunities for networking, followed by a discussion session in which experts provide commentary on the research findings.
wrong.,,,,,,,Chief Executive Officer Craig Dees, Ph.D., observed, "This meeting with the FDA is another significant step forward in streamlining the pathway to initial U.S. approval of PV-10 as the first local agent for recurrent locoregionally advanced melanoma. These patients suffer with troublesome, disfiguring disease that can persist for many years before presenting at distant sites. Our meeting with the Agency established the parameters for submission of a BTD request tailored to addressing the pressing needs of these patients. We're grateful that our work with the Agency, in this and in our previous meetings, to identify a strategy for demonstration of clinical benefit in recurrent patients is bearing fruit. We are very pleased that the path to initial approval in the U.S. is now clear and PV-10 can be available to help patients in a more condensed time frame than if the Agency required an overall survival endpoint in a large randomized Phase 3 study."
The meeting and official meeting minutes provided valuable guidance on a number of issues surrounding the approval path of PV-10:
The Agency agreed with Provectus that treatment of cutaneous and subcutaneous tumors in patients with locally advanced cutaneous melanoma (i.e., recurrent, in-transit or satellite melanoma that has not yet spread from the skin to distant sites) could provide clinical benefit to such patients, particularly if the measured objective responses in patients' disease correlated to a demonstrated treatment effect on one or more symptoms of their disease (e.g., pain, infection or significant bleeding).
The Agency agreed to work with Provectus to quantify symptom control in this patient population.
In reference to discussions on the potential for breakthrough therapy designation, "FDA advised Provectus to provide objective response rates with adequate information to evaluate the symptomatic treatment effects (e.g. pain, infection, bleeding) in patients presenting with locally advanced cutan
investigational drug PV-10 will be featured in a presentation by investigators from Moffitt Cancer Center in a Poster Highlights Session of the American Society of Clinical Oncology (ASCO) Annual Meeting at McCormick Place, Chicago, IL, May 30-June 3, 2014. The time and date of the presentation are expected to become available on the ASCO website
1.7 Millions dollars out of their pockets over the last 11 weeks to exercise options....
i guess you feel sorry for mgmt exercising 1.2 million non-qualified options over last 11 weeks .... total cost to exercise was 1.7 million dollars.... guess what they never sold a share you troll
Date Insider Shares Type Transaction Value*
May 19, 2014 SCOTT TIMOTHY PHD
25,000 Direct Option Exercise at $0.95 per share. 23,750
Mar 20, 2014 WACHTER ERIC PHD
639,248 Direct Option Exercise at $0.75 - $0.95 per share. N/A
Feb 26, 2014 SCOTT TIMOTHY PHD
300,000 Indirect Option Exercise at $1.10 per share. 330,000
Feb 26, 2014 CULPEPPER PETER R
68,624 Direct Option Exercise at $1.10 per share. 75,486
Feb 26, 2014 CULPEPPER PETER R
121,000 Indirect Option Exercise at $1.10 per share. 133,100
yeah maybe all the insiders executives can sue themselves after exercising 1.2m shares over the last 11 week. along with paying fed/state tax of 500k to do so... lol lol lol
Dr. Wachter: I was worried about being able to conclusively demonstrate correlation between this high level of objective response, and I'll use that loosely, what I mean by that is objectively observable response, evidenced by complete responses in patients so that all of their disease is gone after PV-10 injection in 50% of those patients, versus what I knew was very thin data conceding the types of symptoms that the agency was suggesting should be shown improvement in.