"To be blunt, we don't really believe your data."
That was basically the sentiment out of the Food and Drug Administration yesterday, as Johnson & Johnson
A little more than a year ago, the FDA turned down ceftobiprole, requesting "additional audit work of clinical investigator sites and to address specific questions related to site monitoring." It seems Johnson & Johnson's answers to the FDA's questions weren't compelling enough; the agency wants Johnson & Johnson to complete new trials to prove that ceftobiprole works.
And it only gets worse from there.
The health-care giant licensed the drug from Swiss drugmaker Basilea Pharmaceutica, which has already initiated an arbitration request because of the delay. Basilea claims that 10 of 49 clinical investigation sites were deemed unreliable by the FDA or the third-party auditor. Not quite as bad as how Sequenom
Then again, maybe the FDA is just being hard on Johnson & Johnson; drugmakers have to make sure clinical sites are documenting their data properly, but "properly" is somewhat subjective. It sure seems as if whoever is reviewing antibiotics at the FDA has become a stickler, with antibiotics from Theravance
Investors in drugmakers such as Cubist Pharmaceuticals
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