FDA panel said that the company`s preclinical and
clinical data on QT prolongation were acceptable.
"The general tenor of the panel was much more positive
than the tone of the FDA briefing documents," said
Thomas Wei, an analyst at U.S. Bancorp Piper Jaffray.
Five of the 11 panel members at Tuesday`s meeting
recommended approving Ranexa based on the current
available data. The other six members recommended
more data be submitted prior to approval.
JUST MISSED BY ONE VOTE
THE DRUG IS EFFECTIVE
THE DRUG IS SAFE
THE PANEL WOULD LIKE MORE DATA --- GOT IT MORE DATA ---
WAIT FOR FDA FINAL DECISION. YOU MIGHT BE VERY SUPRISED.
FDA CAN`T DISMISS 5 VOTES AS NOTHING.
Puuuh, stellt euch mal vor, daß einer der elf Mitglieder
seine Meinung noch ändern würde
