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

To: Biomaven who wrote (9178)	9/22/2003 1:20:18 PM
From: Icebrg	Respond to of 52153

>>it seems like "Fast Track" is the new biotech nirvana. Easy to get, and produces a 30%+ gain>> Yes, it seems that most "people" believe that FDA is saying: "This is a very promising drug", while in reality the message is: "This is an indication where no-one yet has managed to find anything that works". Erik

To: Biomaven who wrote (9178)	9/22/2003 3:50:42 PM
From: BulbaMan	Read Replies (1) \| Respond to of 52153

FWIW, lots of talk on AXYX Yahoo BB about the company being fast tracked for its Phenserine Alzheimer's drug. FD: I'm long a bit of the stock.

To: Biomaven who wrote (9178)	9/22/2003 8:20:34 PM
From: Miljenko Zuanic	Respond to of 52153

<<Any suggestions for "Fast Track watch?">> ONXX for 9006!

To: Biomaven who wrote (9178)

9/23/2003 12:20:50 AM

From: michael_f_murphy

Read Replies (1) | Respond to of 52153

FDA: Fast Track, Priority Review and Accelerated Approval

Definitions and some examples with respect to oncology from
accessdata.fda.gov

Fast Track refers to a process for interacting with FDA during drug development. Priority Review applies to the time frame the FDA targets for reviewing a completed application. Accelerated Approval (Subpart H) applies to the design and content of the studies used to support a marketing claim.

Fast Track is a formal mechanism to interact with the FDA using approaches that are available to all applicants for marketing claims. The Fast Track mechanism is described in the Food and Drug Administration Modernization Act of 1997 (FDAMA). The benefits of Fast Track include scheduled meetings to seek FDA input into development plans, the option of submitting a New Drug Application in sections rather than all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints (see Accelerated Approval below). The Fast Track designation is intended for the combination of a product and a claim that addresses an unmet medical need, but is independent of Priority Review and Accelerated Approval. An applicant may use any or all of the components of Fast Track without the formal designation. Fast Track designation does not necessarily lead to a Priority Review or Accelerated Approval. An FDA Guidance on Fast Track Designation provides more detail with a citation of the relevant portion of the statue as an Appendix.

Priority Review is a designation for an application after it has been submitted to the FDA for review for approval of a marketing claim. Under the Food and Drug Administration Modernization Act (FDAMA), reviews for New Drug Applications are designated as either Standard or Priority. A Standard designation sets the target date for completing all aspects of a review and the FDA taking an action on the application (approve or not approve) at 10 months after the date it was filed. A Priority designation sets the target date for the FDA action at 6 months. A Priority designation is intended for those products that address unmet medical needs. Internal FDA procedures for the designation and responsibilities for a Priority Review are detailed in the Manual of Policies and Procedures. Applications that were designated as Priority in the Division of Oncology Drug Products are listed here.

Accelerated Approval or Subpart H Approval is a program described in the NDA regulations that is intended to make promising products for life threatening diseases available on the market on the basis of preliminary evidence prior to formal demonstration of patient benefit. The studies are designed to measure and the FDA evaluation is performed on the basis of a surrogate marker (a measurement intended to substitute for the clinical measurement of interest, usually prolongation of survival) that is considered likely to predict patient benefit. The approval that is granted may be considered a provisional approval with a written commitment to complete clinical studies that formally demonstrate patient benefit. The Federal Register published a discussion of Accelerated Approval with comments. Absent a formal demonstration of patient benefit, a risk benefit assessment cannot be made. Accelerated Approval designation does not necessarily lead to a Priority Review. Applications that were granted approval under the Accelerated Approval or Subpart H program in the Division of Oncology Drug Products are listed here.