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Biotech / Medical : Provectus Pharmaceuticals Inc.
PVCT 0.0649-0.2%Nov 14 3:58 PM EST
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Pogeu Mahone
To: dirkdiggler who wrote (12080)6/12/2013 11:37:18 PM
From: NTTG1 Recommendation  Read Replies (1) of 13111
 
The company was slow to 'lock data' after completion of the PII trial; then they had to confront the poor clinical response in stage IV and nodal stage III patients (now to be excluded from phase III trial design). It is likely that they tried several times to convince FDA that increased cumulative dosing should be allowed in the PIII trial, and during that time have been unsuccessful in finalizing their protocol. At this point, waiting a bit longer to incorporate info from the PI MOA studies is not unreasonable, as they may shed light on the company 'immune' MOA story that could play into final study design (new secondary end points or timing of sample collection to document responses).

Dosing and MOA issues should have been worked out years ago. Back pedaling this late in the game takes time (3 years is not unreasonable, but strange that they did not press harder to get a trial started in Australia?). Unfortunately in that time the MM market has filled with a host of interesting new molecules and MOAs.

It is likely that big pharma see's over-valued assets in PV-10 and PH-10 (based on product data available today, market advances by others, and current PVCT market cap) hence little interest in going at risk with research funding or a buy-out deal.

A regional deal for HCC that included a commitment to fully fund development with up front and performance payments is still a possibility to keep PVCT afloat, but an MOU or thin commitment would be very troubling.
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