Replies to post #248316 on Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

In reference to the non-binding term sheet you said:
"If it failed or was withdrawn Leo is obligated to report that in a quarterly filing."

I asked:
"Would that apply to the B-OM BTD as well? Or a SPA submission?"

I couldn't follow your brief response, which was:
"If they are included in a Q or K filing, then yes."

The BTD was announced as a milestone in an 8-K but at that point the fact that it had actually been applied for wasn't established. That fact was established in a PR on 9/20 (http://www.ipharminc.com/press-release/2018/9/20/innovation-pharmaceuticals-provides-corporate-update-highlighting-upcoming-milestones-and-events). The fact that the FDA is reviewing it at that point is all we really know given that it wasn't mentioned at all in the latest 10-Q and the covering press release (just like the term sheet).

The SPA submission was announced in a 2/26/16 PR (http://www.ipharminc.com/press-release/2016/11/12/cellceutix-submits-special-protocol-assessment-request-to-fda-for-phase-3-clinical-trial-of-brilacidin-for-absssi) and subsequently that submission was described in a 10-Q filed on 5/9/16.

In the 10-K filed on 9/13 the Company said this (highlights added):
The Phase 3 protocol SPA request included specific questions from Cellceutix to facilitate a meaningful dialogue with the FDA on the proposed study design. We have received from the FDA comments and considerations for incorporation into our study design. We are now preparing our response. Additional rounds of review may occur, which can extend the review period and be beneficial in reaching agreement with the FDA on design elements. Based on the FDA’s feedback, we may reach final agreement with FDA or may decide to incorporate the advice into the design of the Phase 3 clinical study without undergoing additional rounds of review. FDA’s assessment of the SPA request, and all related feedback, are valuable in the development of Brilacidin for ABSSSI. Contingent upon the outcome of the forgoing SPA request, a U.S. and international study [may] be initiated.

But meanwhile on July the Company filed an 8-K reporting and attaching "an interview" (actually I believe it was a list of questions to which Dr B responded) on 7/13 with its new President in which he said:
"As it stands currently for ABSSSI, we have planned a response to FDA for the Special Protocol Assessment, but we are delaying its submission."

If you followed that you undoubtedly noticed that AFTER announcing the delay of the submission of a SPA response a 10-K was issued that didn't mention a delay at all.


Here's the point:
Investors are entitled to rely on the Company's public statements whether they are made in a filing or a press release. Making a distinction suggesting that the Company had or didn't have an obligation to update the status of a given material agreement based on the venue in which it was announced isn't based on any rule.
The issue in the case of the term sheet is simple....it wasn't binding and the Company itself announced simultaneous to its signing that it may not result in a binding agreement. If a material binding agreement had been entered into there would have been a filing. The lack of a filing to date SHOULD (if IPIX is playing by the rules) mean that either the term sheet has gone the way of the dodo OR is ongoing, but to say that "The lack of mention is actually evidence that it is ongoing" is false.

[frrol]

They state in the SEC filings that there is no guarantee of them closing a deal, nor getting BTD. They also still state that they are working on licensings. They are covered and a court wouldn't ding them if our current negotiation fell through and they didn't announce it, nor if we didn't get BTD. It would suck if these didn't happened, and I think both are still in play, we just don't know without them explicitly stating so.

People just come to wrong hard conclusions when it suits them, and that's foolish. (See posts that "management has P results and it failed". Foolish.) Better to foolishness and focus on what is disclosed and reasonable.

If we don't hear we got BTD next week, it is reasonable to suspect we didn't get it, given company disclosures and the FDA rules. (Doesn't mean we absolutely didn't, just that it's reasonable to suspect. We may have been asked for supplemental info, which could delay it.)

GLTY and all fellow longs!