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

Cell Therapeutics' Pixantrone: Priority Review or Not?

BOSTON, Mass. ( TheStreet) -- It appears the Food and Drug Administration and Cell Therapeutics (CTIC - Get Report) are at odds about the game-changing attributes of the latter's experimental cancer drug pixantrone for the treatment of non-Hodgkin's lymphoma (NHL).

In a strangely worded press release issued last Monday, Cell Therapeutics said that "FDA opts for standard review" of pixantrone. That would be a huge disappointment, of course, since a standard review takes 10 months. The Street's expectation -- and the company's guidance -- was that the FDA would grant a priority, six-month review.

But then the press release states, "Cell Therapeutics to discuss merits for priority review -- final decision due September 4."

Discuss merits with whom? The company doesn't specify. CEO Jim Bianco is quoted in the release saying, "We look forward to working with the FDA and their final decision on our request for priority review."

"Final decision?" So, the FDA opting for standard review was a preliminary, non-binding decision? It sounds as if Cell Therapeutics is appealing the FDA's ruling, hoping to convince the agency to change its mind and speed up the pixantrone review.

Nothing, it seems, is ever straightforward when it comes to Cell Therapeutics.

For the record, this is how FDA regulations define a standard, 10-month drug review: "Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies."

And this is how FDA classifies a drug for priority, six-month drug review: "A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists."
1 of 3

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
CTIC $1.84 -1.34%
AMGN $171.69 0.13%
BIIB $317.00 1.17%
PLX $1.59 -3.64%
AAPL $122.37 -0.50%

Markets

Chart of I:DJI
DOW 17,745.98 -5.41 -0.03%
S&P 500 2,108.63 +0.06 0.00%
NASDAQ 5,128.7850 +17.0520 0.33%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs