Provectus Pharmaceuticals Inc. Message Board

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Biotech / Medical : Provectus Pharmaceuticals Inc.

PVCT 0.0630

-1.6%

Nov 28 9:30 AM EST

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To: Howard Williams who wrote (11214)	4/30/2012 1:16:46 PM
From: NTTG	2 Recommendations of 13111

Interesting, thanks for posting. Of course the FDA did accelerate the final approval steps several years ago, is is exploring 'rolling PIII designs" to reduce the overall cost and time required to complete successful trials.....but it is very unlikely that they will give up the PIII requirement in the patent protected lifetime of PV-10. For most drugs that have gone through accelerated review processes have been approved with the proviso that the sponsor set up registries and REMS programs to monitor and address potential side effects that were not encountered in PIII trials, but happen in the real world. fda.gov fda.gov fda.gov fda.gov Bottom line; is that there is no easy way to accelerate the process and assure patient safety. The FDA is actually moving away from approving drugs with 'similar efficacy' to other therapies, because the unknown risk with no benefit is a real safety concern. The proposed mechanism in this paper would be great for agents with a demonstrated superiority response (head to head) in PII trials, but that really would not apply here. Would be interesting to see how much 'overhead' is spent on investigators and study centers in todays research environment. Cutting the Inst profit could go a long way to reducing the cost driver for PIII trials....just a thought

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