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"This has had an enormous impact," Johnson & Johnson's (JNJ -0.2%) head of global regulatory...

"This has had an enormous impact," Johnson & Johnson's (JNJ -0.2%) head of global regulatory affairs says during a congressional briefing on the FDA's power to grant Breakthrough Therapy designation. Bloomberg highlights JNJ and Pharmacyclics' (PCYC +1%) recent NDA for ibrutinib and notes that, thanks to the new designation, the companies will likely get a response from the regulator two years ahead of schedule.
Comments (2)
  • "the companies will likely get a response from the regulator two years ahead of schedule."

     

    Good to hear. I didn't realize it took that long to get a response.
    25 Jul 2013, 10:51 AM Reply Like
  • responses from the fda take 30 days, the time frame mentioned here is the time from when data begins to be collected until prescriptions can legally be written, usually 3 to 7 years being cut by 2 years is the importance they were trying to convey
    25 Jul 2013, 09:10 PM Reply Like
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