Provectus Biopharmaceuticals Inc (PVCT)

[vorlon1966]

The Big Picture

I am the guy who said he was not worried...lol. Does that make me an idiot?...maybe. But I understand how the drug works on all levels, I also understand how the industry works to some degree.

When the drug makes it through PIII the total amount spent getting there will be about $150mm or less compared with the industry average of $1.3 to 5 billion.

http://www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs/

http://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine/

Does this make management inept?....I don't think so. Has the process gone smooth as it was hoped for?....obviously not...but all in all things are not that bad. Many jumped in hoping for a quick payday and that did not happen....welcome to biotech. The FDA turned down the BTD on a technicality (no PIB data.....but even if they tried to acquire it there would still be no PIB data to measure). Why did they try then for the BTD?...because the FDA suggested they go that route. Is that contradictory?....yes. One must realize that there are many groups in the FDA....ones that guide a company and ones that give approvals....those groups ended up not agreeing.

What about those bashers who ridicule PV-10 being derived from a dye? The whole modern drug business came right out of the commercial dye industry....the first antibiotic was a dye.

http://www.cbmh.ca/index.php/cbmh/article/view/40/39

So what is ahead?

Enrolling PIII, Running PIII and getting it to the midpoint of the study where big pharma sees that the data should be the same as the second half of PIII.....the point they usually step in. Big pharma will know at that point that the data will be enough for a NDA once the FDA gets a NDA application.

Historically after a drug has had 30-50 patients reach the 4-6 month point the independent DMC takes a peak at the progress compared to the comparator.

http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm127073.pdf

If the investigational drug is fairly safe and is statistically more effective than the comparator then they usually ask the FDA to shut the study down early, switch the comparator group to the new drug, and recommend proceeding to NDA.

Recruitment is stopped in a PIII when you show you have the better drug:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2014474/

Everyone would have been happy with a BTD with a bridging study...in all likelihood the bridging study and the PIII would have been about the same amount of time.

Everyone feel better now?