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Posted On: 09/11/2020 3:23:57 PM
Post# of 72447
Farrell, Leo has not requested a pre-IND meeting (as of 9/
, so the delay is not due to the FDA.
http://www.ipharminc.com/press-release/2020/9...gy-reports
The briefing package should be submitted to the FDA at least 4 weeks before the meeting.
https://www.fda.gov/media/72253/download (Page 7)
https://www.fda.gov/media/89217/download (Page 5)
If the FDA has granted a meeting, I think Leo would have announced it in the last PR.
, so the delay is not due to the FDA. Quote:
In separate news, the Company will be submitting a briefing package shortly to the FDA in preparation for our planned clinical study of Brilacidin for COVID-19.
http://www.ipharminc.com/press-release/2020/9...gy-reports
The briefing package should be submitted to the FDA at least 4 weeks before the meeting.
https://www.fda.gov/media/72253/download (Page 7)
https://www.fda.gov/media/89217/download (Page 5)
If the FDA has granted a meeting, I think Leo would have announced it in the last PR.
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