Cempra

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anonymous said:
Does anyone here see any concerns with approval based on the safety data released earlier? "Grade 3 ALT elevations (>3-8xULN) occurred in 8.2% of solithromycin patients and 3.4% of moxifloxacin patients". Liver safety issues led to the downfall of another macrolide Ketek, how different are these signals that the ones seen with Ketek?
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Yes, I do.

Signed,

The FDA
 






anonymous said:
Cempra is a broken business model in the making. So the plan is to sell Solithera on the merits of lower resistance vs the existing macrolides and safety over levo? Not happening. The safety of Solithera is the higher concern. "treatment-related adverse events were higher in the solithromycin (34.3%) arm as compared to moxifloxacin (13.1%)" , given the prior history with Ketek and liver toxicities I would be much more concerned with the safety of a new unproven antibiotic versus levo which has been used for 20 years in millions of patients. The tendon rupture is a non-issue with the fluoroquinolones, the incidence is just 30 or so per 100,000 patients treated and not enough to sway most physicians to abandon levo.

"40% of the levofloxacin and azithromycin CABP prescriptions are written by only 4% of the prescribers of these two products. Levofloxacin and azithromycin represents the majority of the CABP market". The problem is less than half of those prescribers are accessible. Once Cempra realizes this, it is likely they will opt to partner with a large pharma company with a presence in the primary care/pulmonology markets to promote Solithera. Any sales related jobs at Cempra are temporary at best.
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This post from July was so dead on accurate it's scary.
 












anonymous said:
The FL manager is a piece of work. Run if you still have the chance.

May not matter, though, after today's news. Job market is rough. Good luck on your next job search...
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must be same nutcase. terrible reputation! n. carolina rep told me horrible stories about her at his old company. drug got denied not going anywhere now. karma that's right!
 






























There is a lot of hate here.

First of all, karma? So you dislike some random manager, the **company** gets a CRL, and you scream "karma"? Really?

Second, there are no safety issues. The FDA was wrong and incompetent, and so are you. And if you think you are right, feel free to read through these 42 pages and let me know why you think you are right.

http://seekingalpha.com/article/4044221-cempras-solithromycin-great-fda-echo-chamber
 






anonymous said:
Cempra is a broken business model in the making. So the plan is to sell Solithera on the merits of lower resistance vs the existing macrolides and safety over levo? Not happening. The safety of Solithera is the higher concern. "treatment-related adverse events were higher in the solithromycin (34.3%) arm as compared to moxifloxacin (13.1%)" , given the prior history with Ketek and liver toxicities I would be much more concerned with the safety of a new unproven antibiotic versus levo which has been used for 20 years in millions of patients.

"40% of the levofloxacin and azithromycin CABP prescriptions are written by only 4% of the prescribers of these two products. Levofloxacin and azithromycin represents the majority of the CABP market". The problem is less than half of those prescribers are accessible. Once Cempra realizes this, it is likely they will opt to partner with a large pharma company with a presence in the primary care/pulmonology markets to promote Solithera. Any sales related jobs at Cempra are temporary at best.
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The signs were all there in Post #11. The blind arrogance of Prabha underestimated the Ketek legacy in the approval process. DM and JC were too dumb to know that the the first rule is do no harm.
 












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