SI
SI
discoversearch

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.
Biotech / Medical : Biotech Valuation
CRSP 51.18-2.0%3:59 PM EST
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: Sam Citron who wrote (5823)3/8/2002 12:16:02 AM
From: Vector1  Read Replies (1) of 52153
 
Sam and Zeev,
The FDA is a moving target. To some degree this is unavoidable. When additional information becomes available or serious issues are raised that have not been considered earlier the FDA has the right and the responsibility to raise those concerns and require additonal testing even if they approved a previous trial protocol. However, the problem is this happens way too often and should usually be avoidable. There is little question that the package that SEPR put forth would have been sufficient to approve the drug a few years ago. The FDA is leaderless and is run by scientists who have no concept of comercial reality and are cautious to the point of paralysis. The division that deals with the non-sedating allergy drugs in notoreously difficult. The SEPR clinical development team was very experienced and well advised. The drug has virtually flawless data. Aparently someone at the FDA started asking questions about long term tissue accumulation and the main reviewer did not have the answers. This was a major screw up and SEPR shareholders are paying the price. You can only loose your job at the FDA by approving a drug that turns out to have problems. Keeping a good drug off the market is acceptable. The result for us as a nation is a much more costly drug development process and over the long term fewer efficatious products. In my opinion very bad policy.
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2025 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News