This Day On The Street
Continue to site
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: Chelsea's FDA Panel, Ariad's Future, Bio-Bubble Update

But... the reduction in falls attributed to Northera was not statistically significant. Looking at this graph, it seems impossible that fall reduction wasn't stat sig. The problem, explains Oliveto, is the data on falls were not normally distributed across patients in the study. Simply put, about half of the patients in Study 306B never experienced a fall. Some of the remaining patients experienced a relatively small number of falls, while still other patients fell a lot.

Overall, placebo patients suffered many more cumulative falls than Northera patients, but when you apply traditional biotech statistics to the data, it comes back not statistically significant.

This will be more discussion fodder for the Jan. 14 panel. Oliveto believes that panel members will use their common sense and reach the conclusion that Northera, by reducing dizziness, will also help prevent falls. I agree with him. This is a case where bio-stats don't add value.

One more issue: Durability, or lack thereof. Go back and look at the first graph. The primary endpoints of Study 301 and Study 306B assess dizziness after one week of treatment. A knock on Northera and a reason FDA rejected the drug last year was the absence of data demonstrating an extended benefit for NOH patients.

Chelsea still lacks Northera durability data although Oliveto says FDA has signaled a willingness to approve based on 1-week benefit with a commitment to conduct a longer-term post-marketing study. Chelsea has designed another study which will enroll 450 NOH patients and assess a dizziness reduction endpoint at 12 weeks. The study will also look at fall reduction.

Oliveto said this "durability" study will begin enrolling patients before the end of the year as a demonstration of commitment to the FDA.

Chelsea anticipates fielding questions about durability during the Jan. 14 panel and will respond with data from Study 306B showing a positive trend in dizziness reduction favoring Northera extended out to 8 weeks. This trend is not statistically significant, however.

No one said Chelsea is going to have an easy time at the Northera FDA panel. Like in February 2012, the company will need to present its data well and be prepared to answer some tough questions. My confidence in a positive panel vote lies in the totality of the Northera data which makes a risk-benefit argument. [I should mention Northera's safety data across all the studies is excellent.]
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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
CHTP $0.00 0.00%
ARIA $4.72 0.00%
AMRN $1.27 0.00%
CELG $102.45 0.00%
AAPL $93.99 0.00%


Chart of I:DJI
DOW 15,973.84 +313.66 2.00%
S&P 500 1,864.78 +35.70 1.95%
NASDAQ 4,337.5120 +70.6750 1.66%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs