fda accelerate treatment access

Washington, D.C. - U.S. Senator Kay R. Hagan (NC) has (FEB 2012) introduced the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act to get targeted treatments to patients with serious or life-threatening diseases, in a quick and safe manner. The bill will be referred to the Senate Health, Education, Labor and Pensions (HELP) Committee that oversees healthcare issues. Sen. Hagan is a member of the HELP Committee.

The TREAT Act does this by:

1. Accelerating the review and approval process for treatments that(a)treat an unmet medical need (b) significantly advance the standard of care, or are highly targeted therapies for distinct sub-populations.

2.Enhancing FDA access to external scientific and medical expertise. This is critical in areas where research is on the cutting edge. (a) It allows the FDA Commissioner to better utilize waivers when POTENTIAL CONFLICTS OF INTEREST ARE OUTWEIGHED BY THE NEED TO HAVE INPUT FROM LEADING MEDICAL AND SCIENTIFIC EXPERTS.

See full Bill - http://hagan.senate.gov

April 9th 2012 - latest;

The Senate has released its draft of a bill on accelerated approval changes, largely mirroring Sen. Kay Hagan's (D-N.C.) TREAT Act and giving a strong indication of what could come in a final FDA user fee bill.

The Transforming the Regulatory Environment to Accelerate Access to Treatments Act, or TREAT Act (S. 2113), mostly clarifies the statute on the FDA's current accelerated approval process but - unlike before - would allow sponsors to request the designation themselves. Such requests would be approved or denied within 60 days. The draft would also give the FDA greater flexibility to approve a drug USING SURROGATE ENDPOINTS.

The draft bill, the latest of several floated by the Senate Health, Education, Labor, & Pensions (HELP) Committee, also includes a definition for "breakthrough therapy," a type of innovative drug currently bestowed fast-track status for showing a substantial improvement over existing therapies.

If this Bill gets approved, it would, imo be a game changer for Prima and rapidly accelerate FDA marketing approval. Why?
"CVac treatment demonstrates stabilization of bio marker CA125 initially for 4 months, then for FURTHER 18 MONTHS POST FURTHER INJECTIONS of CVac" (latest investor update).

Phase 2b interim results should serve up more confirmation of above.