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: Transcept Pharma

BOSTON ( TheStreet) -- A reminder that the next Biotech Stock Mailbag Live Chat is scheduled for Friday, July 15 at 12 p.m. ET.

I'll answer your questions and respond to your comments in what I hope will be an informative and fun discussion about the current state of the biotech investment sector. Please join me.

A looming FDA drug approval decision kicks off this week's Mailbag. Charlie W. asks, "What's your best prediction for Transcept Pharmaceuticals'(TSPT) coming up approval decision?"

I'm going with a rejection. FDA is expected to issue its decision on July 14.

Transcept is taking a second stab at FDA approval for a low-dose formulation of the popular generic sleeping drug zolpidem (commonly known as Ambien.) This Transcept sleeping pill, branded as Intermezzo, is intended for people who wake up in the middle of the night but cannot fall back asleep.

The FDA has never before approved a so-called "middle of the night" sleeping pill and rejected Intermezzo in October 2009, due to safety concerns. The FDA wanted more data on Intermezzo's next-day effects, particularly the risk of driving impairment. Regulators were also concerned about the ability of people to take Intermezzo with less than four hours of sleep remaining or taking more than one pill per night.

Transcept conducted a driving impairment study that showed Intermezzo to be safe for people who have at least four hours of sleep before waking. The company also redesigned the Intermezzo packaging and bolstered instructions to lower the risk of dosing errors.

What Transcept did not do, however, is conduct a study to demonstrate that patients who wake in the middle of the night are able to use Intermezzo safely and correctly.

Geoffrey Chambers, who writes the Gekkowire.com biotech blog, pointed out this week that Transcept and the FDA discussed the need for a "pre-approval patient use study." Transcept argued against running such a study, believing the new safety data included in the Intermezzo resubmission was sufficient to assuage the FDA's concerns.

According to Transcept disclosures in regulatory filings, FDA said it would "consider" the company's reasoning for not conducting a pre-approval patient use "in light of the overall resubmission of the Intermezzo NDA, including the data generated in the Intermezzo highway driving study."
1 of 4

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
QCOR $93.60 1.65%
TSPT $30.00 0.67%
EXEL $5.46 -2.20%
SPPI $6.85 0.00%
AAPL $122.77 0.00%

Markets

Chart of I:DJI
DOW 17,568.53 -127.94 -0.73%
S&P 500 2,079.65 -12.01 -0.58%
NASDAQ 5,088.63 -48.8540 -0.96%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs