Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Gold/Mining/Energy : Nuvo Research Inc -- Ignore unavailable to you. Want to Upgrade?

To: Montana Wildhack who wrote (8565)	1/28/2002 8:30:34 PM
From: PlayTheKing	Read Replies (2) \| Respond to of 14101

The DMX conference call made my day! I have never listened to a conference call where the investor relations person asks the question during the Q&A session. This management team plans everything to the last minute detail!! Wasn't DMX going to give detailed projections for the sales in the UK? At least I thought that was mentioned in the last President's report. Unfortunately, I wasn't able to call in to ask why this was not addressed. PlayTheKing

To: Montana Wildhack who wrote (8565)	1/29/2002 10:23:18 AM
From: russet	Read Replies (1) \| Respond to of 14101

By CHRIS ADAMS and SCOTT HENSLEY Staff Reporters of THE WALL STREET JOURNAL WASHINGTON -- The pharmaceutical industry, reviving a debate that has simmered for the past two years, claims that regulators at the U.S. Food and Drug Administration are dragging their feet on new drug applications and plans to raise the issue with the agency and with Congress. FDA approval statistics show that the case the industry has begun to make isn't clear-cut. While there has been a slowdown in approving some types of drugs, approval times for others are holding steady. Further, despite some industry complaints that the FDA's yearlong lack of a permanent commissioner has contributed to the problem, some data indicate the approval situation actually improved slightly from 2000 to 2001. 'Greater Cautiousness' "We are seeing greater cautiousness," said Fred Hassan, chairman and chief executive of Pharmacia Corp., Peapack, N.J. "It is right to be cautious about safety. But we must also get out the new treatments that are needed by patients. We are now beginning to see some new innovations that are approved earlier in Europe than in the U.S. This drug lag is not good." Alan Holmer, president and CEO of Pharmaceutical Research and Manufacturers of America, a trade group, added that "the increase that has occurred in review times since 1998 and 1999 is a disappointment to the industry and to patients. ... Getting safe and effective medicines to patients promptly is just too important ... for us to be able to permit the loss of the momentum that the agency established through 1998 and 1999." Daniel Vasella, chairman and CEO of Novartis AG, said the notion of a slowdown at the FDA "is not just a perception. It's miserable." While his company has had nine drugs approved during the past 24 months, it also suffered two high-profile setbacks last year. But last year, the FDA also approved the Novartis leukemia drug Gleevec in less than three months, the agency's fastest approval ever on a cancer therapy. The FDA divides drug applications into "standard" or "priority" piles; the priority applications represent important new drugs that the FDA aims to decide upon within six months. In 1993, the median approval time for standard drug applications -- the data used by the FDA -- was 26.9 months, according to the agency. That figure dropped steadily, hitting a low of 12 months in 1998. Since then, it bounced around a bit, and stood at 14 months in 2001. One important subset of the standard applications are those for "new molecular entities" -- drugs that are brand new, as opposed to being copycats of existing drugs. For new molecular entities, median approval times hit a low of 13.4 months in 1998, before jumping back up and hitting 19 months in 2001, FDA numbers show. These drugs are important to drug makers since they represent breakthrough products, often in untapped markets. Holding Steady As for the priority applications, the FDA has kept the median approval time for them steady at between six and seven months for the past five years. John Jenkins, director of the Office of New Drugs in the FDA's drug division, said that the FDA is "not slowing down" and that it is "continuing to exceed all goals" that have been established for the review process. And he noted that "even though there has been some variability in the last couple of years" for standard application approval times, "there is still a dramatic improvement" from the early and mid-1990s. While he said that the FDA is "aware of the concerns about approval times, we consider the program to be a great success." Currently up for review is a 1992 law that prodded the FDA to speed up the pace of drug approvals in exchange for fees paid by industry. In the early 1990s, slow approval times were a major concern for drug makers and patient groups. After user fees kicked in, the FDA substantially beefed up its reviewing staff, and the pace of approvals quickened. The law will expire this fall, but the chances for renewal are considered good. -- Ron Winslow contributed to this article. Write to Chris Adams at chris.adams@wsj.com and Scott Hensley at scott.hensley@wsj.com Updated January 29, 2002 12:01 a.m. EST