This Day On The Street
Continue to site right-arrow
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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Ampio Hides Need For New Eye Drug Study in SEC Filing

Stocks in this article: AMPE REGN ALIN ROG

Seeking Alpha's Brian Wilson believes Ampio Pharmaceuticals  (AMPE) is on the fast track towards a 2014 FDA approval filing for the diabetic macular edema drug Optina. 

He's wrong. Ampio's recent SEC filings paint a far more uncertain picture about Optina.


This drug [Optina] is being developed under a 505(b)(2) pathway, meaning that it can be FDA approved after completion of its current clinical trial. This is possible because of a FDA rule that would let Ampio use clinical trial data collected from other sources in its NDA, meaning that the company can utilize data supporting the use of danazol for other indications. The 450 patient Phase III trial is nearing completion, and should produce data in 2014 that will be usable in a submission for FDA approval...

In its most 10-Q for the September quarter, filed on Nov. 8, Ampio strikes all mention of Optina's development under the FDA's 505(b)(2) pathway. 

The disappearance of the 505(b)(2) language is strange because in previous quarterly filings with the SEC going back to the middle of 2012, Ampio was quite adamant about reaching agreement with FDA on an accelerated clinical development path for Optina. Optina is a low dosage of the steroid danazol, which has been in use for more than 30 years.

For instance, this is how Ampio described Optina in its 10-Q for the March 2013 quarter:

The FDA granted Optina 505(b)(2) status in July, 2012, and we commenced enrollment in the clinical trial in February 2013. Drugs designated under this pathway can be approved on a single trial.

You won't find those two sentences in Ampio's most recent 10-Q. 

Here's why. In a prospectus filed on Sept. 26 tied to Ampio's most recent financing, the company slipped in new Optina disclosures:

While we believe the data from a single clinical trial would support a NDA filing, we will assess the need for an additional trial in conjunction with the FDA upon the successful outcome of the trial in support of a 505(b)(2) NDA. The FDA has previously indicated that a Phase III trial may be necessary following the current trial. [Emphasis mine.]

The "current trial" has enrolled 250 of a planned 450 patients with diabetic macular edema, comparing Optina to a placebo over 12 weeks of treatment.   Results are expected in the first quarter of next year.

As I've previously reported, the FDA has never approved a drug for diabetic macular edema based on a 12-week clinical trial. Roche (ROG), Regeneron Pharmaceuticals  (REGN) and Alimera Sciences  (ALIM) all ran one-year and two-year studies of their respective diabetic macular edema drugs. There's little reason to believe FDA will lower approval standards for Ampio, which means the ongoing study won't be enough. 

Hence Ampio's new disclosure about the need for another Optina clinical trial -- hidden in an SEC filing where Ampio promoters like Seeking Alpha's Wilson don't bother to look. 

-- Reported by Adam Feuerstein in Boston.

Follow Adam Feuerstein on Twitter.

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.

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
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!


DOW 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs