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

MAP Pharma's Awkward FDA Silence

According to these FDA rules, a company with a drug application acceptable for resubmission hears back from the agency within 14 days. If FDA continues to have problems with a resubmitted drug application, the company will also be informed but not necessarily within 14 days.

Navidea heard back from FDA in 14 days that the Lymphoseek resubmission was accepted. MAP Pharma is now on Day 29 of not hearing anything from FDA about the Levadex resubmission.

Levadex is an inhaled formulation of DHE, a drug already used in intravenous and nasal spray formulations to treat migraines. MAP Pharma developed a device that allows patients suffering from acute migraines to inhale the drug into their lungs, thereby accelerating pain relief.

FDA rejected Levadex in late March for what the company claims were outstanding problems related only to the manufacturing process for the device. The FDA did not raise safety concerns, including the possibility that migraine sufferers inadvertently take more than one Levadex dose at a time, MAP Pharma claimed. After meeting with FDA in June, MAP Pharma said it had all the data necessary to resubmit Levadex without needing to conduct new clinical trials or making additional refinements to the device.

MAP Pharma has been embroiled in FDA controversy in the past. The company had long claimed Levadex clinical trials were conducted under a Special Protocol Assessment (SPA) agreement with FDA. But later, MAP Pharma was forced to acknowledge that no Levadex SPA existed.

-- Reported by Adam Feuerstein in Boston.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
2 of 2

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
NAVB $1.68 0.00%
AAPL $126.44 0.00%
FB $87.28 0.00%
GOOG $523.40 0.00%
TSLA $280.02 0.00%

Markets

DOW 17,730.11 -27.80 -0.16%
S&P 500 2,076.78 -0.64 -0.03%
NASDAQ 5,009.2140 -3.9090 -0.08%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs