The failure of Tovaxin phase II study was disclosed in September 2008, so we're talking about almost two and a half years of repeated promises from Opexa's management.
Opexa issued a press release Wednesday announcing that it had completed two "successful" meetings with the FDA, which offered "positive feedback" about Tovaxin. Opexa now "believes" it can advance Tovaxin into a phase III study.
"Believes" is an interesting word in corporate legalese. It's a form of insurance, designed to insulate any CEO from liability if something goes wrong. For example, "We signed a contract believed to be worth $10 million" is a much different statement than "We signed a $10 million contract." As a biotech observer who focuses on fundamentals, I pay attention when a company relies too heavily on the word "believes."
Opexa states in the release: "Based on positive feedback from the FDA, Opexa
believes it is now positioned from a regulatory perspective to advance with a pivotal Phase 3 clinical study of Tovaxin in MS."
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV