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


To: Mimbari who wrote (11672)11/17/2012 12:58:05 PM
From: NTTG3 Recommendations  Read Replies (1) | Respond to of 13111
 
I would hardly refer to myself as an industry leader, but I do work in the industry and have first hand knowledge of the drug development process; both big pharma and investor supported biotech approaches. Those who are amazed that PVCT has gotten 'so far' with 'so few dollars spent' have missed the point.

PVCT saved money by not doing PII dose ranging (single vs repeat administration, cumulative dose range comparator groups, etc) or comparator controlled studies. Clearly the FDA has not been impressed with the post-hoc dosing analysis the company has presented. As a result, the company has lost the ability to include stage IV and rapidly progressing patients into their proposed PIII trial design. Potential partners will be leery of the limited indication this will bring; they are already paying billion dollar fines to DOJ for over-promoting drugs claims where no claim exists (2.3 billion by Pfizer for practices involving 5 medications, nearly a billion for Lilly promotion of Zyprexa, the list goes on and on)...they are not going to stretch the case here.

PVCT has also tried to save money by not doing the critical studies needed to establish a bystander effect in patients, which will further limit the commercial prospects compared to PVCT self-declared interests.

With regard to information you read on blogs I am threatened by MGT from commenting directly, so I will simply encourage you to review blog projections and actual PVCT deliverables...don't be overly impressed by lists with subjective claims, and diagrams cobbled together with parts of the story....the company is at 52 cents per share with a failed IPO attempt, no publications of the MM PII data, and no tangible progress on PV-10 or PH-10 clinical next steps heading into the final lap of 2012...those are hard performance based realities.

By example...Merck recently launched a PII study in MM for their PD-I candidate that includes patients randomized to one of two drug doses or a comparator arm; supported by numerous basic science and pre-clinical published and abstracted studies. While I have some concerns about the comparator aspect for their trial, in short order they will have more direct knowledge of the market potential for their drug than PVCT investors know about PV-10, you will not know that information for another 3-4 years...still money well spent?

BTW, what is your background in asserting that my information is wrong?