Some info from Camargo on what they expect going in to and after a pre IND meeting with the FDA. This meeting is only 1 hour long, 30 min in some cases.
Published in 2017, they had already lead 1100 + FDA meetings, so I reckon they know these ropes extremely well by now. Camargo conduct up to 6 pre IND meetings a month.
Very exciting to have these guys in our corner going into this, just look at the dot points, will let you fill the rest in, link below:
- What Is Pre-IND Meeting Success?
- Preparing for a Pre-IND Meeting
- What Happens in a Pre-IND Meeting?
- Dos and Don’ts for a Pre-IND Meeting
https://camargopharma.com/resources/blog/pre-ind-meetings-achieve-success-505b2/
"The FDA typically only grants one meeting for each milestone such as Pre-IND, End-of-Phase, and Pre-NDA meetings. This makes the conduct and preparation for these meetings critical."
Looks like were in very good hands !!
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- Ann: Positive IHL-675A in vivo results and FDA Pathway
Ann: Positive IHL-675A in vivo results and FDA Pathway, page-99
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