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


To: Khris Smith who wrote (11700)12/8/2012 2:50:37 AM
From: NTTG1 Recommendation  Respond to of 13111
 
The advantage of a SPA has already been wasted by the company as PVCT heads to the end of 2012 with no approval for a PIII, after nearly 18 months of negotiating the final data lock for their PII trial. Would agree that China is culturally not an easy market to negotiate in, and note that India is a country that has started to revoke international pharma patents to favor local product production. Since PVCT only holds 'use' patents for PV-10 (alone or in combination with other therapies) and PH-10, and product compounding is fairly straight forward, and RB can be bought from a number of suppliers; it would not take much motivation for India or China to pass on the current patents and go into their respective markets with their own versions. Not hard to see how current patent scope exceeds available data to support claims.

Prospects for an independent path in Australia is a serious opportunity to get a trial started. Still suspect the US sticking point is dosing, Australia might allow aggressive disease patients to be included again. PVCT prospects increase significantly if they can keep those patients to the study mix. PVCT is probably not in a strong position to successfully harmonize US and EX-US interests, the path of least resistance is always best for cash strapped companies.

Either way, it will be years before investors know anything conclusive about how PV-10 compares to a conventional therapy in any CA disease state.....an intended omission that is still difficult to understand at the cusp of a PIII.