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gi197845

01/10/18 6:18 PM

#275 RE: bigcat2 #274

Wow Bigcat2, you can't even type a coherent sentence. What are you trying to say? Go back and look at what you typed! Shame on you!

grizzly2314

01/10/18 6:34 PM

#277 RE: bigcat2 #274

I may be wrong but I believe it was mentioned by one of the reviewers or FDA members that an ABPM study could be done fairly expeditiously.

buckiii2

01/10/18 8:47 PM

#278 RE: bigcat2 #274

I hope your right.

jasonn69

01/11/18 11:49 AM

#281 RE: bigcat2 #274

the FDA normally follows the advice of the committee 90+% of the time however there are a few exceptions but it is rare!!!!

P.S. keep an eye on ARDM today !! currently halted. think this will get approval today

TIME: 8:30 a.m.

EVENT: Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 56975) holds a meeting of the Antimicrobial Drugs Advisory Committee to discuss new drug application (NDA) 210693, ciprofloxacin dispersion for inhalation, sponsored by Aradigm Corp., for the proposed indication of treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.

DATE: January 11, 2018

LOCATION: College Park Marriott Hotel and Conference Center, 3501 University Boulevard East, Chesapeake Ballroom, Hyattsville, Md.

CONTACT: Lauren Tesh, 301-796-9001, AMDAC@fda.hhs.gov