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Re: BonelessCat post# 246228

Wednesday, 10/24/2018 12:48:44 PM

Wednesday, October 24, 2018 12:48:44 PM

Post# of 403658
... unless the partner is global and needs EMA approval for EU region distribution/sales. Then process wouldn't be predicated upon just FDA.

If you had said “BTD much more immediate” I would agree. But, no, I didn’t say it was more important because it’s not. OM can move on without the BTD, it can partner without the BTD, but it can’t do either without the end of phase meeting. The BTD expedites Phase 3 through approval and adds value to both OM and IPIX, but nothing goes anywhere without the FDA’s input.

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