respect to eprodisate (KIACTA(TM)), the Company submitted a
proposed protocol for the second Phase III clinical trial for consideration
by the U.S. Food and Drug Administration (FDA) and the European Medicines
Agency (EMEA). EMEA has agreed with the study design including the new
primary endpoint focusing on renal events and excluding death. In addition
both the FDA and the EMEA have recognized that this second clinical trial
will be confirmatory; hence a p-value of less than 0.05, rather than the
p-value of less than 0.01 for the previous Phase II/III trial, should be
sufficient to gain approval of eprodisate (KIACTA(TM)) for the treatment of
AA Amyloidosis,. A follow-up meeting with the FDA to finalize the study
details should take place in the very near future.
Consolidated Financial Results Highlights
BELLUS Health Inc., formerly known as Neurochem Inc., (BELLUS Health or
the Company) is a global health company focused on the development and
commercialization of products to provide innovative health solutions to
address critical unmet needs.
The shareholders of Neurochem Inc. approved the change of its name to
"BELLUS Health Inc." at the annual and special shareholders' meeting on
April 15, 2008. The new stock ticker symbols of the Company are BLUS
(NASDAQ) and BLU (TSX).
The Management's Discussion and Analysis (MD&A) provides a review of
the Company's operations, performance and financial position for the three-
and nine-month periods ended September 30, 2008, compared with the three-
and nine-month periods ended September 30, 2007. It should be read in
conjunction with the Company's unaudited consolidated financial statements
for the periods ended September 30, 2008, as well as the Company's audited
consolidated financial statements for the year ended December 31, 2007,
which have been prepared in accordance with Canadian Generally Accepted
Accounting Principles (GAAP). For discussion regarding related-party
transactions, contractu
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Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Related medicine news :1.
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