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


To: Miljenko Zuanic who wrote (5829)3/8/2002 10:09:57 AM
From: Vector1  Respond to of 52153
 
Miljenko and Rick,
after a good nights sleep I would like to take back the "bunch of hacks" comment. I was obviously very frustrated yesterday. I am still licking my wounds. I was as quite surprised by the FDA action as was the company and most of the street. I am sure there are many excellent fine hard working scientists at the FDA.

Also there was a typo in my post. I wasn't suggesting allergies are life threatening. I was suggesting that the standards for NON LIFE-THREATENING conditions were being raised. Whether that is good public pollicy is debatable. Changing the rules of the game in the middle or at the end is not IMO.

As to who dictates the tone of the negotiation, I do have some experience with the FDA. They have all the power and I believe absolute power corrupts absolutely. The FDA should be held accountable. Assuming SEPRs management was led down a road in discussions with the FDA and led to believe they had submitted an acceptable package the FDA should have to explain why they changed their minds at the last minute and the reasons should have to make good scientific sence.

Finally, with regard to Longo's comments. The failure of drugs in late stages of development and the general perception in that FDA approval is a crap shoot even with excellent clinical data raises the cost of capital for all companies in the sector resulting in a decrease in spending on new drugs. In my opionion that is simply bad policy.

V1