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Biotech / Medical : Provectus Pharmaceuticals Inc. -- Ignore unavailable to you. Want to Upgrade?


To: travisnye who wrote (12139)6/29/2013 8:39:10 AM
From: NTTG1 Recommendation

Recommended By
Pogeu Mahone

  Read Replies (1) | Respond to of 13111
 
There will have to be a PIII trial to get PV-10 to market for MM in the US, any other suggestion is a smoke screen. BTD, AA are interesting opportunities for a select group of well documented drugs that have been driven through development by highly engaged management teams who have partnered with big pharma early to lay the ground work for approval.

Those companies have 10-40 full time employees who work with regulatory issues and submissions, clinical development, clinical trial support, and publication strategies all focused on developing their science and marketing stories, that is not PVCT....this is a simple licensing company that can not secure key US based partners for PV-10 or PH-10.

PVCT is not delayed because of a problem at the FDA, or the scientific community not understanding what they are trying to do....they are delayed because PVCT has not demonstrated the basic elements of their story.

They may get a PIII for stage III MM off the ground some day, and it will be interesting to see what their human MOA studies reveal (strangely not mentioned yet as a talking point on Thursday) , but it looks increasingly likely that this is becoming an ex-US product development candidate for HCC, which sets the clock back quite a bit for investors.

Those who suggest the problem is with FDA re-organization are beating a very dead horse