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Actionable news in CEMP: Cempra, Inc.,

Cempra (CEMP) CEO Dr. Prabha Fernandes on Q4 2015 Results - Earnings Call Transcript

Solithromycin has all these properties of the previously approved macrolides, the potency, a targeted spectrum of activity, good tissue distribution, and the anti-inflammatory effects. Solithromycin has been shown in non-clinical tests to be better in these properties than the older macrolides and has potent activity against resistant strains. Solithromycin is mostly bactericidal, which means it kills the bacterial pathogens, unlike the older macrolides, which only stop the growth of bacteria.

With all of these powerful characteristics, we believe solithromycin will be an important therapy in the treatment of CABP and the oral formulation could allow treatment of patients on an outpatient basis, or to discharge patients from hospitals sooner, and in all the medications that is prevalent through the intravenous medication, which is what we showed in our Phase-III trials.

Last year, the FDA took some important steps with two significant designations for solithromycin. Last August, the agency granted Fast Track designation for solithromycin intravenous and capsules for the treatment of CABP. This allows a rolling NDA. This is on top of the FDA designation of solithromycin IV and capsules for the...


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