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

To: Lee N who wrote (669)	5/10/1999 6:50:00 PM
From: KLH	Read Replies (1) \| Respond to of 2344

Further info on last weeks earnings release: biz.yahoo.com

To: Lee N who wrote (669)	5/10/1999 10:39:00 PM
From: Jibacoa	Read Replies (1) \| Respond to of 2344

<<Would sure help an investor know when to jump in>> I already jumped in quite a while ago with my two feet and keep "jumping" further in every chance I get. Good luck to all. Bernard

To: Lee N who wrote (669)	5/19/1999 9:21:00 PM
From: Dan Hamilton	Read Replies (1) \| Respond to of 2344

Lee, I finally found some information (on FDA's web site) concerning approval rates of new drugs...this is drawn from a document entitled "From Test Tube to Patient: New Drug Development in the United States". Phase 1 Number of Patients: 20-100 Length: Several months Purpose: Mainly safety Percent of Drugs Successfully Tested: 70 percent Phase 2 Number of Patients: Up to several hundred Length: Several months to 2 years Purpose: Some short-term safety but mainly effectiveness Percent of Drugs Successfully Tested: 33 percent Phase 3 Number of Patients: Several hundred to several thousand Length: 1-4 years Purpose: Safety, dosage, effectiveness Percent of Drugs Successfully Tested: 25-30 percent For example, of 100 drugs for which investigational new drug applications are submitted to FDA, about 70 will successfully complete phase 1 trials and go on to phase 2; about 33 of the original 100 will complete phase 2 and go to phase 3; and 25 to 30 of the original 100 will clear phase 3 (and, on average, about 20 of the original 100 will ultimately be approved for marketing). Based on this, there doesn't appear to be much fall off from Phase II to III. But it looks like only 2/3 of those clearing Phase III actually get approved. That seems surprisingly low. The FDA's CDER Annual Report for 1998 indicates some improvement in overall approvals, but they don't say exactly what the improvement is.