IntelGenx Technologies Corp. (NASDAQOTH:IGXT)

zzlangerhans (99.75) Submitted: 10/7/2011 4:07:21 PM : Start Price: $0.50 IGXT Score: +6.26

I know this will shock everyone, but IntelGenx is dumb. Their peak achievement thus far has been getting CPI-300, a high-dose buproprion tablet accepted for review by the FDA. The first NDA didn't go so well, with the FDA returning a CRL due to a manufacturing issue and a food effect. The company claims to have resolved both issues, and a PDUFA for the CPI-300 resubmission has been set for 11/13/11. The reason for my green thumb here is that I think it is very likely the FDA will approve CPI-300 this time round.

If my thesis is correct, you'll see the fastest switch from a green thumb to a red thumb since CAPS was born. As far as I can tell, CPI-300 is simply a higher dose of buproprion than is currently available in generic tablets, an effect which can be duplicated by simply combining generic tablets. IntelGenX has a website which looks like it was composed by a 12 year old having a bad day. The website contains a lot of general information about proprietary drug delivery technology, but virtually no information about CPI-300. Rather odd for the central issue in the company's future.

The FDA is tasked simply with determining if a proposed drug or device is safe and effective. If a pharma chooses to develop and submit a drug which is commercially non-viable, that is not part of the FDA's decision making process. So my prediction is a very short-lived pop on approval of CPI-300, followed by fairly rapid degradation of the share price to zero unless the company is able to pull offf a substantial dilutive financing.