Provectus Pharmaceuticals Inc. Message Board

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Biotech / Medical : Provectus Pharmaceuticals Inc.

PVCT 0.0697

-0.4%

3:55 PM EST

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To: jm2i123 who wrote (10860)	2/21/2012 10:32:29 PM
From: NTTG	2 Recommendations Read Replies (2) of 13111

I believe the Roche product is approved in the US already ( fiercebiotech.com ). Basically, any cancer chemotherapy who's success can be 'linked' to a specific gene defect moved to the front of the clinical use line since the genotyping is easy and the knowledge of high probability response is powerful. What predicts PV-10 clinical success? More basic to the issue is that even if the company gets an application submitted by March of 2012 and gets a stellar review and approval in 6 months..clinical trials will not realistically begin in the US till Q1 2013. Allovectin took close to 3 years to recruit their PIII trial (luckily they were receiving milestone payments throughout)...so earliest that results would be available would be late 2016 (seems to be taking PVCT quite a while to get analysis of 90 patents done...dont think the PIII will be any easier). FDA filing in 2017...review time..earliest possible approval date is 2018, more likely 2019 IMO. In the mean time, oncologists will continue to learn how to use newly developed gene directed therapies, vaccines and immune modulators to improve clinical outcomes. Unless PV-10 decides to go head to head with Yervoy or Zelboraf (which I doubt) they will be relegated to a comparison with DTIC or Temodar, agents which are already being eclipsed by todays advances in therapy.

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