Rivulet Media Inc (fka RIVU)

[Jobrano]

read:New FDA 'breakthrough' status speeds OK

Drugmakers may win approval from U.S. regulators for "breakthrough" therapies after a single round of studies, rather than three, in an effort to speed them to patients, a Food and Drug Administration official said.

The agency assigned three promising experimental medicines the new status to try to reduce the time needed to get them to market against life-threatening diseases.

Bio-Matrix Scientific Group and Entest BioMedical Finalizes New Immuno-therapeutic Cancer Vaccine Joint Venture with Therinject
Initial Market to Be Veterinary Medicine -- $60 Million Potential

This BMSN biotechnology Company that trades on the bb's with a total market valuation of several million dollars could represent a spectacular trade opportunity for smart early investors.

Breakthrough status means the companies will have closer communication with top FDA staff to move drugs for serious diseases to market more quickly, potentially with data from an expanded Phase 1 trial, Woodcock said. Improved understanding of diseases is leading to more candidates for this status.

"We expect many of these would come available very quickly with Phase 1 data," BMSN!!

New drugs generally need three phases of testing focusing on safety and effectiveness to win FDA regulatory approval.

In addition to the three treatments that have won the new designation, 18 other drugs have applied to gain the new status, most for types of cancer.

The breakthrough designation was created in legislation passed last year reauthorizing the FDA's user fee programs for drug and device reviews. The agency didn't receive authorization to hire more full-time employees for the enhanced communication and is attempting to balance its priorities.

"We don't want to disadvantage ordinary drugs.

In contrast to the breakthrough drugs,the agency is taking its time to consider whether to approve copies of biotechnology medicines, so-called biologics.

While the FDA has been contacted BMSN in connection with 12 biologic therapies, the agency is meeting with companies one by one instead of drafting guidelines on specific classes of drugs.

Big news for BMSN can hit any moment for the market.

Time to buy.

Koos is invested in this stock at a much higher price

http://www.openinsider.com/search?q=bmsn