FDA Considering Allowing Developers of Critical Drugs/Treatments to Conduct Smaller, Faster Clinical Trials
October 22 2012 - 7:20AM
Marketwired
The Food and Drug Administration Commissioner Margaret Hamburg has
told scientific advisers that the FDA is considering a faster
pathway for obesity treatments, life-saving antibiotics and other
drugs deemed to offer societal benefit. The Paragon Report examines
investing opportunities in the Biotech Industry and provides equity
research on AspenBio Pharma, Inc. (NASDAQ: APPY) and Sunesis
Pharmaceuticals, Inc. (NASDAQ: SNSS).
Access to the full company reports can be found at:
www.ParagonReport.com/APPY
www.ParagonReport.com/SNSS
Under the new pathway the FDA would allow developers of such
drugs to conduct smaller, faster clinical trials, and provide a
"special medical use" label which would allow doctors to administer
drugs to patients with critical need. Hamburg has said that the FDA
needs to take into account the needs people with deadly or
debilitating diseases that may be willing to take on the risks of
unproven drugs.
"A pathway that would allow products to come to market faster
but would ensure they were used only in patients where there was an
applicable risk-benefit situation would be good," said Pew Health
Group's Allan Coukell, deputy director of medical programs. "It
would be good for developers, for companies and it would be good
for public health."
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AspenBio Pharma is an in vitro diagnostic company focused on the
clinical development and commercialization of its blood-based
appendicitis test. The company announced that it plans to initiate
a pivotal study in the fourth quarter of 2012 for its blood-based
appendicitis test.
Sunesis is a biopharmaceutical company focused on the
development and commercialization of new oncology therapeutics for
the treatment of solid and hematologic cancers. Sunesis has built a
highly experienced cancer drug development organization committed
to advancing its lead product candidate, vosaroxin, in multiple
indications to improve the lives of people with cancer.
The Paragon Report has not been compensated by any of the
above-mentioned publicly traded companies. Paragon Report is
compensated by other third party organizations for advertising
services. We act as an independent research portal and are aware
that all investment entails inherent risks. Please view the full
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