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MinnieM

12/01/14 4:23 PM

#80028 RE: Pepperchino #80027

I agree. There has been no confirmation of meeting date by the company. All they have said is a meeting in December. We have no idea as to whether or not CTIX has a private meeting on another date. Especially, since their meeting will cover both the antibiotic and psoriasis drug. I just prefer not to pin down a date the company hasn't specified.





In Reply to 'EasyRider'
Here is what I could find. I can't seem to confirm if we are meeting with the FDA on this day though, or Friday, which is a continuation of the 2-day meeting.

Dec 4th Anti-Infective Drugs Advisory Committee meeting:
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm420134.htm


2014 Advisory Committee Tentative Meetings
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm153468.htm


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vip1999

12/01/14 5:05 PM

#80032 RE: Pepperchino #80027

according to the site

Agenda

The committee will discuss issues related to clinical development programs and clinical trial designs for antibacterial products for the treatment of patients with serious bacterial infections for which there are limited or no therapeutic options.

Meeting Materials

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.