Amarantus Bioscience Holdings Inc (AMBS)

[JJAAMMAANN]

Should be getting pretty interesting around here by say...July timeframe...The RPDD should take around 6 months to decide.

http://www.amarantus.com/news/press-releases/detail/2038/amarantus-requests-rare-pediatric-disease-and-orphan-drug


http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm


Therare pediatric disease priority review
voucher fee is intended to cover the
incremental costs for FDA to do a
priority review on a human drug
application that would otherwise get a
standard review. The formula provides
the Agency with the added resources to
conduct a priority review while still
ensuring a robust rare pediatric disease
priority review voucher program that is
consistent with the Agency’s public
health goal of encouraging the
development of new human drugs and
biological products for rare pediatric
diseases.
A priority review is a review
conducted with a PDUFA goal date of 6
months after the receipt or filing date,
depending on the type of application.
Under the PDUFA goals letter, FDA has
committed to reviewing and acting on
90 percent of the applications granted
priority review status within this
expedited timeframe. Normally, an
application for a human drug or
biological product will qualify for
priority review if the product is
intended to treat a serious condition
and, if approved, would provide a
significant improvement in safety or
effectiveness. An application that does
not receive a priority designation will
receive a standard review. Under the
PDUFA goals letter, FDA has committed
to reviewing and acting on 90 percent of
standard applications within 10 months
of the receipt or filing date depending
on the type of application. A priority
review involves a more intensive level
of effort and a higher level of resources
than a standard review.
Section 529 of the FD&