Ampio Blames Shorts But Won't Answer Legitimate Questions About Its Drugs

GREENWOOD VILLAGE, Col. ( TheStreet) -- Instead of addressing questions about its drug-development plans posed by critics, Ampio Pharmaceuticals ( AMPE) blames short sellers for trying to destroy the company.

On Friday, Ampio Chairman and CEO Mike Macaluso accused Seeking Alpha contributor Joe Dredly of trying to intentionally "damage the existing shareholders by triggering a downward pressure on their stock holdings."

In his statement, Macaluso also links Dredly with Peter Bortel, a hedge fund manager who wrote a series of negative articles about Ampio in 2011. While writing about Ampio, Bortel was also "working with a group of short selling speculators" and under investigation and a cease-and-desist order from the Securities and Exchange Commission, Macaluso claims.

This all sounds very sinister, which is what Macaluso wants investors to believe. In reality, Ampio's response is just a lazy, diversionary tactic. By attacking the credibility of its critics, the company hopes investors won't realize or care that responses to legitimate questions remain unanswered.

Bortel's Pegasus Investment Management did get into some hot water with the SEC in 2011, but it was over the erroneous classification of $90,000 in cash payments related to futures trades. The SEC's cease-and-desist order can be read here and has nothing at all to do with short selling or Ampio.

Dredly and Bortel are right to question the legitimacy of Ampio's drugs. I've done the same thing.

In April 2012, Ampio claimed to have reached agreement with regulatory officials in Australia that would allow the company to seek approval for Zertane in June 2012.

I warned investors to be wary of Ampio's misleading claims about Zertane.

June 2012 came and went without a follow-up announcement from Ampio about filing Zertane for approval in Australia. Instead, Ampio issued a press release conceding the company would be required to conduct two, phase III studies of Zertane before seeking approval in the U.S.

One year later, Ampio has still not submitted an approval application for Zertane in Australia, nor has the company started the two phase III studies required before it can seek approval in the U.S. Repeated promises by Ampio management to find a partner for Zertane have also gone unfulfilled.

Ampio spokesman Rick Giles, reached for comment via email Friday, didn't why the company has been unable to meet any of its Zertane timelines.

Likewise, Ampio has yet to explain why the clear failure of a small study of its experimental drug Optina in diabetic macular edema was spun as a success.

A phase III study of Optina in diabetic macular edema is now underway, even though its design falls well short of what's necessary for FDA approval.

Ampio is happy to accuse short sellers of attacking the company but can't respond intelligently to criticisms about a subpar phase III Optina study.

As Dredly also points out correctly, Ampio has also missed or changed its guidance about the development of the osteoarthritis drug Ampion, without explanation. Why did the company change the primary endpoint of a phase II study conducted in Australia last year? Why did the company first claim to reach agreement with the FDA to begin phase III studies of Ampion but then concede the need for a phase II study?

On these important questions, Ampio remains silent.

-- 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.

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