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
See Cramer's multi-million dollar portfolio for FREE and get his new book Get Rich Carefully! Learn More

Biotech Stock Mailbag: Vivus, Chelsea, BioCryst

BOSTON (TheStreet) -- @WilliamPShelley kicks off this week's Biotech Stock Mailbag, asking "What are you thinking about Vivus' (VVUS) panel?"

My predictions for next week's two very important FDA advisory panels:

Vivus: Positive vote! Panel will recommend Qnexa's approval.

Chelsea Therapeutics (CHTP): Positive vote! Panel will recommend Northera's approval.

Who says I'm always Mr. Negativity?

For Vivus, I'm betting on the politics of obesity drugs outweighing the lingering safety concerns about Qnexa. The drug clearly helps fat people lose weight and FDA is under pressure to approve something for weight loss. Qnexa may be saddled with restrictions and safety warnings, but it's going to win this time around.

Chelsea took a hit Monday when it "pre-announced" the FDA's questions (too short clinical trials, patient deaths) related to Northera as a treatment for hypotension, or dangerously low blood pressure, in patients upon standing. It's now up to Chelsea and its advisors to defend the drug and convince the panel to vote yes against what might be strenuous FDA opposition.

This isn't an original observation, but others have likened Chelsea to Acorda Therapeutics (ACOR), which also overcame a tough and highly critical FDA review to win the backing of an advisory panel and ultimately, a full drug approval.

I listened to Chelsea's CEO this week at the BIO CEO & Investor Conference, and I came away feeling like the company has a good argument to make favoring Northera's safety. The bigger question comes down to the endpoints and duration of the clinical trials used to assess the drug's clinical benefit.

Chelsea and FDA reached an agreement in advance on these trial designs. While it's the agency's prerogative to change its mind, I don't think that will sit well with the experts on the panel given the serious nature of this disease.

For that reason, I'm predicting a Chelsea win.

One more Vivus note: As you read this column today (Friday), the FDA will have likely already released its second review of Qnexa. You'll be able to find the FDA's Qnexa briefing documents on the agency's Web site.

Stock quotes in this article: VVUS, CHTP, BCRX, BPAX, EXEL, KERX 

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
DOW 16,505.44 -8.93 -0.05%
S&P 500 1,876.10 -3.45 -0.18%
NASDAQ 4,131.1390 -30.3190 -0.73%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto
Advertising Partners

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs