Intellipharmaceutics International Inc. (IPCI)

[AngeloFoca]

http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm

The above gives a very clear picture of the purpose of the various phases in the trials... and the below gives an in depth view of the process.

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm

Pain Medication studies are notoriously fifficult to conduct due to the extremely high placebo effect... as much as 60% at times... another word, give 10 people a sugar pill while telling him it's pain medication and as many as 6 out of 10 will tell you they feel much better.

So I believe that possibly Rexista+PODRAS may well turn out to be primarily objective Bio Equivalency BE studies rather than subjective standard studies.

Give a patient the medication... take and analyze blood samples on an hourly basis... and based on an existing data base you have an objective map of the effect of the drug... although I think it will, never-the-less, be accompanied by the patients subjective response to the drug.

I think the greatest time period will be the Pre-Clinical work to ascertain it will be safe to administer to the 1st patient in the phase 1 safety test... I actually think that once safety has been established... the phase 3 efficacy test will be a breeze, and should take no more than 6 months and will probably be the lesser requirement.

For those who are wondering if something could go wrong that might result in overdose... I'm sure there will be plenty of Naltrexone at the scene... which reverses the effects of opioids.