This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Biotech Stock Mailbag: Generex, Part II

A phase III study of Oral-lyn is underway that is supposed to enroll 750 diabetic patients and might offer a clearer picture of the product's efficacy and safety. Yet even here, Generex plays stupid games aimed at misleading investors, something that totally undermines the legitimacy of the study.

On March 10, 2009, Generex issued a press release announcing "successful phase III study data" for Oral-lyn, even though the study enrolled only 300 patients, just 60 of which had been on treatment for the requisite six months called for in the study's design.

On past conference calls, Generex has claimed it will file for Oral-lyn's approval with the U.S. Food and Drug Administration as long as the outcome of this single phase III study is positive.

Good luck with that. Never mind that the FDA almost always requires a minimum of two positive phase III studies for drug approvals; in diabetes, the regulatory bar is usually much higher.

Consider MannKind (MNKD), which conducted 44 studies of its inhaled insulin device Afrezza before seeking FDA approval. MannKind tested Afrezza in 5,300 patients total, including multiple phase III studies enrolling hundreds of patients each. Amylin Pharmaceuticals' (AMLN) phase III program for long-acting diabetes medicine Bydureon consists of six studies that enrolled more than 2,300 patients.

And Generex thinks it's going to get the FDA to review Oral-lyn based on some shifty Ecuadorian studies and a single phase III study?

Ha!

Moving on, Charles D. writes, "As a former Cell Therapeutics (CTIC - Get Report) long holder and now interested observer, would you please look into the rumor of Novartis (NVS - Get Report) buying Cell Therapeutics at $2 per share? I find the very notion to be preposterous and laughable, but someone has generated enough momentum that it appears plenty of suckers are buying in. Unless hell freezes over and swine grow wings, I do not see this happening, and thousands are being duped (again, like I was) out of their hard-earned money. I enjoy your writing, especially when you twist the dagger. More journalists should have the same edge."

Novartis is not going to buy Cell Therapeutics for the reasons I outlined quite clearly Wednesday when I detailed the company's fiscal crisis and pixantrone's dwindling commercial potential.
3 of 5

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG
GNBT $0.01 7.71%
CTIC $1.85 0.54%
NVS $103.84 -0.50%
MNKD $4.16 -0.12%
SPPI $6.97 0.00%

Markets

Chart of I:DJI
DOW 17,582.13 -16.07 -0.09%
S&P 500 2,099.06 +1.02 0.05%
NASDAQ 5,115.3750 -0.0070 -0.00%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs