Provectus News Provectus Biopharmaceuticals Me
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Posted On: 02/09/2015 9:19:36 AM
Provectus News
Provectus Biopharmaceuticals Met with FDA on Operational Aspects of PV-10 Phase 3 Melanoma Study
Monday February 9, 2015
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company ("Provectus"
, announced today that it has held a Type C meeting with the U.S. Food and Drug Administration (the "FDA" or the "Agency" to review certain operational aspects of the protocol for its planned phase 3 clinical trial of intralesional PV-10, its novel investigational drug for cancer, as a treatment for melanoma. The meeting was held by teleconference on January 29, 2015.
Eric Wachter, PhD, CTO of Provectus, stated, "As noted in our press release of December 22, 2014, when we submitted the protocol to the Agency in November 2014, we included a brief list of questions about certain operational aspects of the protocol. The FDA subsequently indicated that a formal meeting was appropriate to assure that these questions were addressed in a timely and comprehensive manner. As is typical for such meetings, we provided a more extensive list of questions in the formal meeting package. This led to a very thorough and helpful review of the protocol as a result of the meeting."
Topics formally reviewed included subject eligibility requirements, primary and secondary study end points, and study lesion definitions and conventions for defining disease progression.
Dr. Wachter noted, "We are extremely grateful for the careful review conducted by the Agency. The outcome of the review does not affect the fundamental design of the study nor the patient population, but does affect certain details concerning some secondary end points and statistical analysis matters, such as the treatment of missing data. We are making a number of small changes to the protocol in light of this review, and will issue a final version later this month."
Dr. Wachter added, "We have eight sites, four in the U.S. and four in Australia, in our expanded access program currently using PV-10 for melanoma and other cutaneous malignancies. We expect that they will provide a path to quickly starting enrollment upon completion of the review period. In addition, we have been qualifying additional sites that will join the study pending action by their respective Institutional Review Boards."
For a detailed list of the current inclusion and exclusion criteria and further details regarding the endpoints of the study, visit: https://clinicaltrials.gov/ct2/show/NCT022888...amp;rank=5
The complete press release is available at www.pvct.com/pressrelease.html?article=20140209.1 on the Provectus website.
Provectus Biopharmaceuticals Met with FDA on Operational Aspects of PV-10 Phase 3 Melanoma Study
Monday February 9, 2015
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company ("Provectus"
, announced today that it has held a Type C meeting with the U.S. Food and Drug Administration (the "FDA" or the "Agency" to review certain operational aspects of the protocol for its planned phase 3 clinical trial of intralesional PV-10, its novel investigational drug for cancer, as a treatment for melanoma. The meeting was held by teleconference on January 29, 2015. Eric Wachter, PhD, CTO of Provectus, stated, "As noted in our press release of December 22, 2014, when we submitted the protocol to the Agency in November 2014, we included a brief list of questions about certain operational aspects of the protocol. The FDA subsequently indicated that a formal meeting was appropriate to assure that these questions were addressed in a timely and comprehensive manner. As is typical for such meetings, we provided a more extensive list of questions in the formal meeting package. This led to a very thorough and helpful review of the protocol as a result of the meeting."
Topics formally reviewed included subject eligibility requirements, primary and secondary study end points, and study lesion definitions and conventions for defining disease progression.
Dr. Wachter noted, "We are extremely grateful for the careful review conducted by the Agency. The outcome of the review does not affect the fundamental design of the study nor the patient population, but does affect certain details concerning some secondary end points and statistical analysis matters, such as the treatment of missing data. We are making a number of small changes to the protocol in light of this review, and will issue a final version later this month."
Dr. Wachter added, "We have eight sites, four in the U.S. and four in Australia, in our expanded access program currently using PV-10 for melanoma and other cutaneous malignancies. We expect that they will provide a path to quickly starting enrollment upon completion of the review period. In addition, we have been qualifying additional sites that will join the study pending action by their respective Institutional Review Boards."
For a detailed list of the current inclusion and exclusion criteria and further details regarding the endpoints of the study, visit: https://clinicaltrials.gov/ct2/show/NCT022888...amp;rank=5
The complete press release is available at www.pvct.com/pressrelease.html?article=20140209.1 on the Provectus website.
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Intuitive;
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NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
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