11/11/14 - Provectus Biopharmaceuticals Issues PV-
Post# of 22759
Posted On: 11/12/2014 12:40:29 PM
11/11/14 - Provectus Biopharmaceuticals Issues PV-10 Phase 3 Melanoma Protocol to FDA [Manufacturing Close - Up]
Provectus Biopharmaceuticals has submitted its phase 3 protocol for evaluation of PV-10 for treatment of locally advanced cutaneous melanoma to the FDA.
According to a release from the company, the FDA is expected to review the submission and comment on the proposed study population, clinical endpoints, and statistical analyses within 30 to 45 days.
The submission of the protocol follows completion of the due diligence audit of Provectus' regulatory documents for PV-10 and PH- 10. The purpose of the audit was to ensure that all the regulatory documents were in order.
Provectus anticipates few, if any, significant issues to arise from review of the protocol based on the substantive contact it has had with the FDA since the Company had its Type C meeting with the Agency on December 16, 2013. In particular in its letter of May 16, to the Company, the FDA gave guidance on assessment methods and endpoints that Provectus has incorporated into its phase 3 submission.
Provectus Biopharmaceuticals specializes in developing oncology and dermatology therapies.
More information:
http://www.pvct.com
((Comments on this story may be sent to newsdesk@closeupmedia.com))
(c) 2014 ProQuest Information and Learning Company; All Rights Reserved.
Provectus Biopharmaceuticals has submitted its phase 3 protocol for evaluation of PV-10 for treatment of locally advanced cutaneous melanoma to the FDA.
According to a release from the company, the FDA is expected to review the submission and comment on the proposed study population, clinical endpoints, and statistical analyses within 30 to 45 days.
The submission of the protocol follows completion of the due diligence audit of Provectus' regulatory documents for PV-10 and PH- 10. The purpose of the audit was to ensure that all the regulatory documents were in order.
Provectus anticipates few, if any, significant issues to arise from review of the protocol based on the substantive contact it has had with the FDA since the Company had its Type C meeting with the Agency on December 16, 2013. In particular in its letter of May 16, to the Company, the FDA gave guidance on assessment methods and endpoints that Provectus has incorporated into its phase 3 submission.
Provectus Biopharmaceuticals specializes in developing oncology and dermatology therapies.
More information:
http://www.pvct.com
((Comments on this story may be sent to newsdesk@closeupmedia.com))
(c) 2014 ProQuest Information and Learning Company; All Rights Reserved.
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I'm in it to win it!
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.
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Alway's searching for winners'
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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