The reason why it is going up so much is because when they get FDA approval they ALREADY have the distribution deals in place. Check past announcements/company reports and you will see this. It means as soon as FDA approval is obtained, they will have a monopoly in the US workplace drug testing market for the first saliva drug testing device approved by FDA. The reason why the big US companies dont already buy it is because of the legal risk in using a device that is not FDA approved- big legal issues. With FDA approval these big companies are protected and will buy the oraline in massive volumes as HGR will be the only company selling FDA approved saliva tests.
Also, margins for devices sold in US would be quite high I would expect, and with the millions of devices per year that will be sold by retail distribution networks already in place, over the counter rev from US alone should be around $25 mill USD in the first year after FDA approval. (For over the counter retail sales ALONE)
There are 133 million workplace drug tests carried out per year in the US alone. That doesnt take into account law enforcement, schools, roadside testing, private (remember that total market for workplace drug screening is worth $1.3 billion per annum)
So if HGR gets a good slice of this action within 3-5 years you would expect revenue to be in the hundreds of millions. Only with FDA approval is this possible.
Most of the work is done with the intense testing on marijuana smokers etc to ensure that it works. The FDA has a stringent process to go through to GET TO THE FILING stage. Basically, once the 510k is filed, approval is often a formality moreso with devices as opposed to drugs. HGR wouldn't have got to the brink of filing the 510k without being given a very strong indication that once they are at this point, approval is a rubber stamp.
The other bonus is that no other salive testing device on the market is so precise and calculates small percentages of drugs in the body so accurately and so quickly (within 7 minutes) It is far superior to any other device out there, which includes ALL its competitors (which dont have FDA approval of course). Also it tests for all the 4 major drug groups.
If they announce the filing for the 510k with FDA in the next 7 days, this stock will be trading at a lot more than 3.5 cents. Most monpoly businesses in huge markets with good distribution networks in place make loads of profit.
Do the math
HGR
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