It was GLFD not NFLD, big difference.
A couple of zinger comments!
Confidence Grows at Guilford
Despite FDA Application Delay
By TONY COOKE
DOW JONES NEWSWIRES
April 13, 2005
At Guilford Pharmaceuticals Inc., confidence is trumping experience as insiders again load up on their company's shares.
Four company insiders on Monday reported buying a total of 157,625 shares at an average price of $2.19 a share. Guilford shares closed down 5 cents, or 2.2%, at $2.21 yesterday in 4 p.m. New York Stock Exchange composite trading.
This week's disclosures represent only the latest burst of buying at the Baltimore biopharmaceutical company. From August 2001 through March, Guilford executives and directors reported spending nearly $2.4 million to buy 412,090 shares at an average price of $5.71 a share, according to data supplied by The Washington Service.
Anthony Marchese, the general partner for Insiders Trend Fund LP, noted that Guilford's insiders have a record of buying shares at higher prices. "They've demonstrated an unusual capacity to be wrong constantly," he said. Mr. Marchese said he doesn't doubt the sincerity or confidence of insiders at Guilford -- just their judgment. "I will say one thing: They do believe in the [company's] story."
Guilford co-founder Solomon H. Snyder said he continues to believe. Mr. Snyder, who sits on the company's board, has been the biggest buyer among the company's executives and directors in recent years, reporting the purchase of 378,000 shares for about $4.50 a share, including his recent purchase of 90,000 shares.
Mr. Snyder, a medical doctor who is director of the Department of Neuroscience at Johns Hopkins University Medical School, said the recent suspension of new patient enrollment in Guilford's Phase III study of a sedative for colonoscopy patients will only delay, and not prevent, approval by the Food and Drug Administration.
"The rules of the FDA are that a drug must be safe and effective," he said. "Aquavan is clearly effective -- it puts people to sleep. And we've done enough patients...to indicate that it's safe."
Mr. Snyder said a key purpose of a Phase III trial is to enlist large numbers of patients in order to identify problems that might not have been apparent in earlier, smaller trials.
"The thing you are looking for in a Phase III trial is those bad surprises," Mr. Snyder said, "and we didn't have any of those bad surprises."
The only issue, Mr. Snyder said, was that the dose of Aquavan administered was too high for an appropriate comparison with another sedative. He said the company will work with the FDA to set up a trial using a smaller dose -- or perhaps two smaller doses.
Stacey Jurchison, director of corporate communications for Guilford, said the company now expects to file its new drug application with the FDA in the second half of 2006. The company's previous guidance was that the application would be ready in the first half of that year.
Though Mr. Marchese is skeptical about Guilford's prospects, he expressed admiration for the commitment of company insiders. "I wish them well," he said. "I respect the fact that they have consistently purchased shares in the open market." Ultimately, however, Mr. Marchese said he has to respect the judgment of the market.
Mr. Snyder disagrees. He points to his past purchase of the stock of Scios Inc. when he was a director there and that company's drug for congestive heart failure was still awaiting FDA approval. According to a disclosure made in 1998, Mr. Snyder bought 10,000 shares at $4.75 a share. In 2003, Johnson & Johnson bought Scios for $45 a share.
"Having been in the biotech business for 20 years, I've learned that I don't make my decisions by what Wall Street thinks," Mr. Snyder said. "I do what I think is right and hope Wall Street will catch up."
Write to Tony Cooke at tony.cooke@dowjones.com |
