News Focus
News Focus
icon url

SevenTenEleven

06/13/11 12:35 PM

#6384 RE: AlanC #6383

AlanC, They will only disclose that which they are forced to disclose. The rest will leave the investment community guessing.
icon url

SevenTenEleven

06/14/11 6:53 PM

#6388 RE: AlanC #6383

Neoprobe v. Short Seller Over Lymphoseek

By Adam Feuerstein 06/13/11 - 07:37 AM EDT


DUBLIN, Ohio (TheStreet) -- As Neoprobe (NEOP) prepares to seek U.S. approval for its lymph node mapping agent, a New York hedge fund manager has shorted the stock and is taking an unusual step to prevent the company from getting a review by regulators.

Capital Management filed a citizen petition with the U.S. Food and Drug Administration last week requesting Neoprobe's Lymphoseek be denied a review due to "severe deficiencies and flaws" in the conduct of two phase III clinical trials.

Betting against FDA drug approvals is a well-worn (and often profitable) strategy in Wall Street's biotech trading canon. Shkreli, however, is pushing new boundaries by seeking to directly influence the FDA review process in his favor.

"I'm protecting my interests using whatever means are available to me… I think investors filing citizen petitions should be done more," says Shkreli.

Neoprobe shareholders have taken to various stock message boards accusing Shkreli of using the citizen petition to manipulate the company's stock price unfairly, or perhaps even illegally. Neoprobe share at Friday's close of $3.75 are down 32% since the stock reached a 12-year high of $5.48 on May 31.

Healthcare attorney and regulatory expert Peter Safir says Shkreli is within his rights to lobby FDA in this way.

"The first word is citizen and that means citizen petitions are open to anybody, including investors with a financial interest in the companies involved," says Safir, a partner and co-chairman of the food and drug practice group at Covington & Burling in Washington, D.C. Safir does not represent Shkreli or Neoprobe.

Citizen petitions are rarely if ever filed for altruistic reasons. For example, Teva(TEVA_) is financially motivated to keep a competitive version of Copaxone developed by Momenta Pharmaceuticals(MNTA_) off pharmacy shelves, so the Israeli drug maker has filed three citizens petitions with FDA seeking to delay or derail the agency's review. [FDA rejected all of Teva's citizen petitions but has not yet made an approval decision on Momenta's version of Copaxone.]

Is what Shkreli is doing with respect to Neoprobe any different than what Teva sought to do against Momenta?

"It's unusual," says Safir, referring to Shkreli's decision to file a citizen petition. Most are filed by companies, organizations or their representative law firms. "No one files a citizen petition when it is not in their competitive advantage to do so," he adds.


http://www.thestreet.com/story/11150515/1/neoprobe-v-short-seller-over-lymphoseek.html?cm_ven=emailfriend


Does this Shkreli have an insider that will make sure the FDA approval is denied to protect his short interest?

See related story.

SEC Adds Insider Trading Charge Vs FDA Chemist

by The Associated Press
WASHINGTON June 2, 2011, 08:41 pm ET

http://www.npr.org/templates/story/story.php?storyId=136902178

Federal regulators on Thursday expanded their civil insider-trading charges against a chemist with the Food and Drug Administration accused of using confidential FDA information on pending drug approvals to profit from trades of drug companies' stock.

Cheng Yi Liang is facing both civil and criminal charges of running an insider trading scheme starting in November 2007. He and his son were arrested in March on charges including securities fraud and wire fraud.

The Securities and Exchange Commission said Thursday it filed a revised civil lawsuit against Liang, alleging he illegally traded in advance of a public announcement on FDA approval of XenoPort Inc.'s Horizant. That was the 28th announcement the SEC says Liang traded ahead of, in addition to the 27 cited in the agency's suit filed in federal court in Greenbelt, Md., on March 29.

The agency's revised suit "shows Liang had one more illegal trade in the pipeline when we charged him," SEC spokesman John Nester said in a statement. "That trade was not expected to pay off until after we put a stop to his fraudulent scheme."

Horizant was developed to treat restless leg syndrome. Liang made more than $126,000 in profits on XenoPort's stock, the SEC said. He is accused of making a total $3.6 million in the trading scheme.

Liang's lawyer, Andrew Carter, didn't immediately return a telephone call seeking comment Thursday.

The SEC is seeking unspecified restitution and fines against Liang.

Liang looked up the status of the FDA's review of Horizant on a confidential database at least 52 times between Jan. 6 and March 24, the SEC said. He bought 43,000 shares of XenoPort in accounts in other people's names in February and March.

The announcement of the approval of Horizant came on April 6, about a week after Liang was charged by the SEC and federal prosecutors. It boosted the price of XenoPort stock by 56 percent, according to the SEC.

The new SEC complaint adds an eighth brokerage account to those it says Liang used to avoid getting caught. That one was in the name of his father, the agency said.

The Wall Street Journal reported Thursday that the government has expanded its investigation of insider trading at the FDA to cover other government employees besides Liang. The Journal cited unidentified people familiar with the matter.

Nester declined to comment on the report.

http://www.npr.org/templates/story/story.php?storyId=136902178