Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

It has nothing to do with reduction of expectations other than reducing the overblown importance of BTD as described on this forum. BTD is not at all critical to advancing B-OM to Phase 3 nor is it in any way critical to a partnership or license. B-OM will move forward with or without a BTD.

The importance of BTD is quite limited:
1) BTD can expedite review accelerating movement through the final phases to approval
2) it includes intensive support and rolling review from the FDA which speeds the phase 3 and can shorten a trial
3) it adds to a valuation by big pharma for the terms of licensing

What a lack of BTD does not do:
1) it does not prevent a drug from moving forward into phase 3
2) it does not nullify any agreement or conditions for licensing under regular, unexpedited, review and protocols
3) it will not impact the end-of-phase meeting other than discussing the best path forward under more conventional FDA guidance
4) it will not make B-OM “dead in the water” because it must go through a more traditional pathway to approval

B-OM will move forward with or without a BTD, and no one knows whether or not a BTD was granted until Leo discloses it, or in an EoP post-meeting PR, and announcement of whatever pathway the FDA wants to see.