Stock Market Chumps..........10-23-06

Replidyne, Inc. (RDYN)

Last Trade:	5.39
Trade Time:	12:06PM ET
Change:	4.85 (47.36%)

Biotech drug developer Replidyne Inc. and drugmaker Forest Laboratories Inc. said Monday the Food and Drug Administration won't approve their antibiotic faropenem medoxomil without further clinical trials.

The companies estimate that the required studies will add at least two years to the development of the antibiotic.

Replidyne and Forest, which partnered on the drug in February, are trying to get the antibiotic approved for acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis and uncomplicated skin infections.

While data from 11 late-stage clinical trials and more than 5,000 patients were submitted to the FDA, the companies believe that the FDA has recently started preferring superiority studies -- where a new drug has to be shown better than standard care -- for antibiotics.

The FDA recommended new clinical studies for all indications sought; there were no safety or manufacturing concerns.

Replidyne said it is in a strong financial position to continue developing the antibiotic with Forest. The companies plan to discuss development plans further with the FDA.

Forest shares fell $3.47, or 6.7 percent, to $48 in premarket activity on the INET electronic exchange, after closing Friday at $51.47 on the New York Stock Exchange. Replidyne shares, which trade on the Nasdaq, closed Friday were unchanged in premarket activity.

Neoware, Inc. (NWRE)

Last Trade:	12.00
Trade Time:	12:06PM ET
Change:	2.53 (17.41%)

Hardware and software maker Neoware Inc. said Monday it expects first-quarter sales of about $21.5 million, below Wall Street's consensus estimate.

On average, analysts polled by Thomson Financial are looking for sales of $24.7 million for the quarter, which ended on Sept. 30.

In the fourth quarter, the company posted revenue of $23.5 million.

The company said it will post results on Oct. 30.

Adeza Biomedical Corp. (ADZA)

Last Trade:	15.25
Trade Time:	12:07PM ET
Change:	2.68 (14.95%)

Adeza Biomedical Corp. on Monday said U.S. regulators asked for an additional animal study, and other conditions, before approving Gestiva, its drug to prevent premature births.

The announcement sent the company's shares down about 15 percent, or $2.65, to $15.28 in late morning trade on the Nasdaq.

In a statement, Adeza said an approvable leter from the U.S. Food and Drug Administration also outlined post-approval clinical requirements consistent with recommendations made by the FDA advisory committee in August.

In late August, an advisory panel assembled by the FDA for Gestiva said that although clinical data on the drug were adequate for it to win U.S. approval, future information on possible risks was needed.

"We will request a meeting with the FDA to address comments outlined in the approvable letter as soon as possible," said Emory Anderson, chief executive officer of the Sunnyvale, Calif.-based biotech company.

Gestiva is a long-acting, injectable form of the hormone progesterone.

In a separate statement, pharmaceutical company Columbia Laboratories Inc. said it expects to announce results of its pre-term birth treatment PROCHIEVE's late-stage trial in early 2007.

Columbia expects to submit the application for a label indication with the FDA in mid-2007 in case of positive results, Columbia added.

Columbia's shares rose 15 percent to $3.75 on the Nasdaq.

The company said PROCHIEVE is already FDA approved as part of a reproductive treatment for infertile women with progesterone deficiency and to treat secondary amenorrhea.

Secondary amenorrhea is the temporary or permanent cessation of menstruation in a woman who has previously experienced normal menses.