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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (7793)	1/22/2003 2:44:55 PM
From: Biomaven	Respond to of 52153

U.S. readies plans to speed up review of medicine - Jan 22, 2003 01:32 PM (Reuters) - finance.lycos.com ====================================== By Lisa Richwine WASHINGTON, Jan 22 (Reuters) - U.S. health regulators soon will unveil plans to speed up the review of new medicines by making the process more efficient, the commissioner of the Food and Drug Administration said Wednesday. Mark McClellan, who in November took the helm of the agency that regulates drugs, foods, medical devices and other products, said the FDA "was preparing to introduce a number of new innovations to speed up the drug development and review process. We will have more to say about these steps soon." Drug review times dropped sharply during the past decade after the agency started collecting fees from companies to hire more reviewers. Congress renewed the fee program last year and also created a similar program to cover medical devices. Before the fees, drug reviews took more than two-and-a-half years on average. Today, medicines viewed as important advances are evaluated in six months or less. Drug makers complained, however, that review times slowed in recent years and alleged that FDA reviewers had become overly cautious. McClellan said the agency wants to make the review process more efficient. While he did not provide specifics, he said one way to enhance the system would be to provide clear guidance to drug makers about the FDA's approval standards. "There is considerable evidence that by improving our communication with industry, by being clear about what we need in order to determine a product is safe and effective, we can reduce that time significantly," said McClellan, who spoke at a conference sponsored by the journal Health Affairs and AcademyHealth, a health services research and policy group. During last year's congressional probe of ImClone Systems Inc.'s (NASDAQ:IMCL) cancer drug Erbitux, FDA officials acknowledged that various divisions communicate with drug makers differently, prompting calls for consistent communications. Consumer groups, meanwhile, have charged the industry fees have led to the agency reviewing medicines too quickly and letting drugs with too many risks on the market. As part of the fee program passed by Congress, the FDA will strengthen monitoring of drugs' safety in the first few years after approval, when it is most likely that side effects undetected during clinical trials may occur, McClellan said. The agency plans to hire 50 additional employees for the increased post-marketing surveillance, he said. In addition, the agency is reviewing petitions to move some prescription drugs to over-the-counter status, McClellan said. In November, the FDA granted a request from a health insurer to switch Schering-Plough Corp.'s (NYSE:SGP) allergy drug Claritin to nonprescription status. "Where evidence indicates a drug can be used safely and effectively by a population without the need for a prescription ... then we believe the drug should be over the counter," he said. Copyright 2003, Reuters News Service

To: Biomaven who wrote (7793)	1/22/2003 2:56:05 PM
From: nigel bates	Respond to of 52153

Anyone follow them? You're not entirely alone - Message 18473563 nig

To: Biomaven who wrote (7793)	1/22/2003 3:40:05 PM
From: keokalani'nui	Read Replies (1) \| Respond to of 52153

Peter, I followed it since it was spun out from Applied Biosystems (pre acquisition, by PE?) more than a decade ago--before I was a biotechnick. So, luckily, I didn't buy high and sell low, although I did add some at the old $3, when there was financing activity and news about MPSS. I took my losses late last year. The company made several progressively enormous mistakes not going out for money when it was available. I think they even canceled one set to go at $25 or $12 when the market was tanking. I will tell you that I think the company consistently failed to inform its shareholders just how nearer they were to the still-needs-to be-developed side of being a development-stage company. i lay this at the feet of Sam Eletr. They HAVE to operate at cash flow or they are dead, so there is now some spending discipline. They are doing the best they can as a contract tissue sample analyzer. This barely keeps the lights on, and will get them to complete prototype protein profiler, hopefully. Watch for the Protein Profiler. If 2d separations and analysis could be significantly improved, and if PP meets the needs of the market, this invention will be the most certain saving of your investment and at this price a very, very fine, multiple return. But the technology still awaits a feasibility and development collaboration with a manufacturer--I think. The posters on SI who know of such things would be able to make a killing if they were able to forsee commercialization of this technology. If they do foresee its adoption, I hope they will come find me because I won't but irrationaly feel I deserve to. The next most important event--in my view (some people focus on the Eurpean collaborations and the JV)--is the data from the ISB's use of Megaclone, Megasort etc. in its systems approach to prostate cancer. This is the MOTHER of all feasibility studies for Lynx. The Hood/ABI/lynx/brenner connections runs repeatedly throughout this little company's history; but frankly it was a shock how late in Lynx's life (well too late to support a fiancing) this collaboration occured. As an example of its use by the ISB, and possible limitations and competitors, listen to Hood's presentation at CapCure 9/02. That is all for now. My family's taken a broadside we are all tying to come to grips with, so I'll be off an on for a while. Best, Wilder