I'm not concerned at all about the FDA facility inspection. It's not like this is their first product, they've been making CholesTrak for years and should have these FDA inspections down cold by now. I would imagine that the HIV and other testers are basically a modification of the Cholestrak tester, with differently treated paper and different chemical mix in the buffer reservoir. What the FDA likes to look at closely is paper, paper, paper, (and not the test strip in the tester, but what is in the file drawers) and CMTR should know how to put their paper together by now, they've had the systems in place for years. FDA inspections tend to screw up new manufacturers more often than the older ones, particularly when you make your clinical samples in an R&D lab mimicking a production environment, and then for product launch you try to bring the production facility on-line quickly so that it's ready when you get your approval. Also, facility deficiencies are often readily and quickly fixed, more of the i dotting and t crossing types of things. Unlike what FDA criticisms on your clinical methodologies can do ie.) go back to square one and start over. Also, who says that this blood test technology can't be readily adapted to saliva technology in the future by CMTR. This seems to be a fairly versatile tester design and I would venture to guess that what you are looking for in spit isn't going to be much different than what you are looking for in blood. Also, blood tends to be less influenced by outside things such as that cup of coffee or water you just drank, or that hot pepper on your sandwich at lunch that you can taste the rest of the day, etc. Saliva tends to get contaminated with other compounds much more so than blood, and thus I wouldn't expect the saliva tests to be as readily reliable. Do you know how long the ASTRA-MERCK contract is for? Myself, I put more value on the H.pylori test than the HIV one as they are late to market versus the competition, thus they'll probably all beat each other up on price. Pylori is out there all over the place in a huge percentage of the populace and virtually untreated in most - bet everybody knows somebody with an ulcer caused by it (whether they know it or not). When the guy who discovered this bug (camphlobacter pylori back then) in Austalia published his findings, he was treated like he was telling everyone that the world is round when everybody KNOWS it really is flat (Ulcers are caused by stress not bacteria, quit worrying and have another valium). I believed him. Hell, they had to change the name of it to Helicobacter just to distance it from the discoverer.
I'd much rather see them sell some more shares than run out of cash, better dilution than liquidation. |
