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

Aviron Says Flu Drug Won't Be as Late as Feared

Biotech company Aviron (AVIR) said Monday it is confident it won't have to conduct additional clinical trials for its flu vaccine before getting the treatment approved, based on feedback from the Food and Drug Administration.

On Friday, the FDA sent Aviron a "complete review letter," which detailed the steps required to get the experimental FluMist nasal spray vaccine approved. Aviron said Monday that the FDA has "requested additional information and clarification regarding clinical and manufacturing data" to support FluMist's application.

Aviron added that it still needs to clarify some of the FDA's requests, and the company did not predict how long it will take to respond to the FDA's questions, or how long regulators will take to review the new information.

But Aviron should be able to get FluMist to market in time for the 2002-2003 flu season. If it does, it will be one year behind schedule. Hopes to have the vaccine ready this year were dashed on July 27, when an FDA advisory panel did not recommend the drug's approval because of safety concerns, despite finding FluMist effective.

If the FDA had asked Aviron to conduct more tests, FluMist could have been delayed even further.

Monday's announcement should provide some support for Aviron shares, which have lost half their value since the July 27 setback. Aviron closed Friday at $22.39 per share.

If approved, FluMist would be the first flu vaccine taken as a nasal spray by healthy adults and children. The drug will be co-marketed by American Home Products (AHP - Get Report).

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
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.
Submit an article to us!
SYM TRADE IT LAST %CHG
AHP $16.34 1.10%
AAPL $131.33 -1.00%
FB $80.96 -1.20%
GOOG $553.88 -0.27%
TSLA $230.36 -0.51%

Markets

DOW 18,075.30 +37.33 0.21%
S&P 500 2,112.52 +3.60 0.17%
NASDAQ 5,060.1680 -0.0780 -0.00%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs