Replies to post #249884 on Innovation Pharmaceuticals Inc (IPIX)

[bradfordbros]

So the shadow of a potential partner not sitting at the table has been removed. Thanks Sox.

[loanranger]

Nice post and thanks for the link.

It doesn't answer this question, though, in terms of IPIX.:
"I wonder if such a thing fits the FDA's meeting rules."
If anything it suggests that the FDA may not let IPIX bring a plus one.

Per the example....
The Developer said to the 3 BPs with a special interest: "if they’d like a seat at the table for the EOP2 meeting with FDA, then term sheets are due by X date, and full contract must be executed by Y date."
A full contract at the time of the Meeting would clearly establish that the BP was a party that the FDA could consider to be "from the requester’s organization", thereby justifying their presence at the meeting. That full contract is what that Developer sought and in fact demanded prior to the meeting.
Currently, as far as I know (and I think it's consistent with all the publicly released information) IPIX has "only" signed a non-binding term sheet and as I understand it it includes an indication (IBD/UP) that isn't a subject of the meeting at all. One thing that is obvious from the Guidance pdfs is that the FDA takes these meetings seriously, demanding that the package provide the focal points and the areas the Developer hopes to have addressed and the amount of time they expect each topic to take. A full contract provides the FDA comfort that they don't have a participant at the meeting posing questions and using their valuable time, that may turn out to have simply been a looky-loo.


ps. Where can I find this SitTight person?

pps. Obviously some record of an EOP2 sponsor enjoying the company of a BP prior to the execution of a full agreement at their end of phase meeting would be welcome.


...and because it's interesting, part one:
https://www.locustwalk.com/time-will-kill-your-dealbut-in-deal-making-timing-is-everything-part-one/