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

To: Londo who wrote (5825)	3/8/2002 1:00:17 AM
From: Vector1	Read Replies (4) \| Respond to of 52153

Longo, Your agrument that there are other drugs on the market that are almost as good and are safe misses the point. While I agree that the FDA should be protecting us from "snake oil" or worse, creating impossible and unclear standards increases the cost and therefor the price to the consumer for new drugs. It also frankly destroys any incentive to develop improved products for all buy life threatening diseases. Not a result that I would like to see. SEPR's failure with Soltara is especially alarming because they followed on agreed upon clinical trial development plan and had trial results that werer virtually flawless. By the way if Soltara is as efficatious as Hismanol (and the clinical data suggests it is at least as good) then it is clearly better than what is on the market. Do you have allergies. Claritin is a friggin sugar pill. Hismanol was clearly the best in class in terms of efficacy and onset of action. Ask any allergist. The FDA's responsibility is not just to keep unsafe products off the market but to create a set of regulations and requirements that make the development of beneficial drugs something less than the crapshoot it has become. Increasing the cost of drugs is of benefit to no one. You can imagine how frustrating it is for a company's management who devote their careers to developing a drug. Follow all of the FDAs clinical requirements and then have the rules of the game changed. If the regularory protocol was working well there would be very few durgs submitted for NDAsthat were not approved. The companies would clearly know after they completed their data analysis whether they had an approvable drug. The companies that had drugs that could not meet the clear standards would not go to the effort and expense of submitting an NDA. The fact that so many companies are getting rejected after submission is clear evidence of a major problem. Yes the FDA should be run by scientists but do you think the best and the brightest are at the FDA. The sad truth is that for the most part they are a bunch of hacks who could not make it in the commericial arena or academia. They should be held accountable for their decisions and the rules should be carefully developed so that companies do not spend hundreds of millions of dollars following protocols that do not lead to approval despite flasless trial data. V1