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Re: $heff post# 100323

Wednesday, 07/15/2009 4:07:35 PM

Wednesday, July 15, 2009 4:07:35 PM

Post# of 137481
$heff, Thanks for NSPH, I am holding some ADLS also, they are close to a ruling too. I don't understand the "efficacy" argument. If it works, it works.

Advanced Life Sciences [[ADLS]] Cethromycin NDA (once-daily antibiotic for the treatment of community acquired pneumonia - CAP) is pending with an expected PDUFA decision date of 7/31/09. On 6/2/09, ADLS announced that the FDA’s Anti-Infective Drugs Advisory Committee voted in the majority that Restanza (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate CAP (11 positive, 3 negative, 1 abstaining). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP (3 positive, 11 negative, 1 abstaining).

"Tis surprising to see how rapidly a panic will sometimes run through a country.
Their peculiar advantage is, that they are the touchstones of sincerity and hypocrisy, and bring things and men to light that might otherwise have lain forever undiscovered.

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