Soon or not soon enough. Seems the current situation.

Not saying this is the case, but since the board is tossing around numbers: assuming fully diluted the share count is ~250 million, a billion dollar offer would net ~$4 a share. Yes, I’d take that.

However, B-UP and -OM together would net ~$1 billion in upfront and potential milestones to market. How that filters out depends on perceived risk for the licensee. 90%-95% of the risk would be structured in the back end: benchmarks, milestones and after market royalties.

Nonetheless, there would still be the rest of the IBD (assuming IBD was not in the package) left to negotiate along with oral K.

$1-$2 billion buyout does seem fair at this point.

For your edification:
“Termination means ending. It is true no matter how someone left a company (voluntarily or involuntarily, fired or quit or laid off). When anyone is no longer working, the employment is terminated. Dismissal is an action led by the employer which results in Termination of employment.”

Lack of a BTD does not exclude the benefits of a BTD. Nearly all the benefits of a BTD can be included once fast-track is granted:

A drug that receives Fast Track designation is eligible for some or all of the following:

*More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

*More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers

*Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

*Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm

Examining breasts and nipples during a hair loss examination seems normal. Bertolino’s poor bedside manner (in this case not explaining the purpose) is common in the profession and may be a reason for leaving his practice.

A quick answer to the lady’s question wasn’t hard to find:

“Fluctuations in hormones can cause a variety of symptoms, including darkening nipple hair. These fluctuations can occur during times of significant hormonal change, such as pregnancy and menopause. Subtle hormonal changes also occur in a woman's 20s and 30s, and they can result in changes in your hair as well. Jul 21, 2017
What Causes Hairy Nipples and How Can You Remove the Hair? - ...”

Here is what inclusion criteria states for treatment:
“Platinum resistant/refractory disease, defined as disease progression/relapse within 6 months following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively”

Do we know if either or both were concurrently undergoing platinum treatment? I don’t recall seeing that in any report.

Though tumor size was a secondary measurement for the Phase 2a. The primary outcomes were:
“Number of Participants With Treatment-Emergent Adverse Events [ Time Frame: 6 Weeks ]
Reporting of Adverse Events, and severity of adverse events

Number of Participants With Changes in Biomarkers [ Time Frame: 3 Weeks ]
Changes in RNA and/or protein level of pre-specified biomarkers associated with the p53 signalling pathway and apoptosis will be compared between pre-treatment sample (tumor biopsy, ascites fluid, and peripheral blood) and post-treatment sample (tumor biopsy, ascites fluid, and peripheral blood)”

Similarly, tumor size was also a secondary outcome. Primary outcomes:
“Maximum Tolerated Dose (MTD) of Kevetrin [ Time Frame: up to 6 months ]
A dose will be declared the MTD if at least 1 patient out of 6 patients experience a dose limiting toxicity (DLT) at the highest dose level below the maximally administered dose. Once an MTD has been established, up to 12 additional patients may be enrolled at the MTD dose level for confirmation of safety.
The maximally administered dose is if 1 or more of 6 patients experience a DLT.

Dose Limiting Toxicities (DLT) of Kevetrin. [ Time Frame: up to 4 weeks ]
The definition of dose limiting toxicity (DLT) is in accord with the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Dose limiting toxicity will be defined as:
Grade 3 or 4 neutropenia complicated by fever, or greater than 38.5°C documented infection, or Grade 4 neutropenia of greater than 7 days duration
Grade 4 thrombocytopenia or grade 3 thrombocytopenia complicated by hemorrhage
Any grade greater than 3 non-hematologic toxicity unless there is clear alternative evidence that the adverse event (AE) was not caused by Kevetrin
Grade 3 diarrhea, nausea, or vomiting may be excluded from dose-limiting toxicities provided that the maximum time limit for supportive measures is 48 hours.”

Kevetrin is a P53 modulator and repair. Though it was hoped that it would reduce tumors, it was always considered to be primarily effective as a combination therapy.

According to Leo:
“Estimates vary as to the market size (in dollars) of an effective OM treatment, for HNC-only patients, across major markets (U.S., Europe and Japan), ranging between $500 million and $1.5 billion on an annual basis (sources: GlobalData; Redington Inc., pdf). One company in the OM space projects the worldwide OM market opportunity to be as high as $2.6 billion annually.”

Using the lowest estimate, $500 million globally would generate $50 to $75 million upfront plus benchmark payments to NDA and market of another several hundred million. Striking a deal would cause a run to over a 1 dollar and perhaps 2. A .30 to .50 price reflects an end of p2 report that includes fast-track elements with rolling review. A deal puts the SP 4 to 8 times higher.

No, they didn’t make a new company to separate KARD from IPIX. The separation was more physical than legal. The CRO and biopharma were always two separate companies, one private and one public. The two shared the same suite of offices and lab space, only.

However, there were many agreements between the two, including shares paid to KARD to fund preclinical work on ultimately all 3 platforms, work that began before the formation of CTIX but resulted in shares for mouse studies.

If a deal is struck B phase 3 will cost IPIX nothing. The licensee or partner will be responsible for costs from that point forward. Upfront money and milestone payments will go to further development of other drugs and indications. Your assumption that IPIX will pay is dead wrong, unless Leo fails to license OM, then we are all pretty much out of business. It’s my opinion that there will be a license; the question is the terms: upfront, benchmarks and royalties.

All those other questions you raise become moot with the close of any deal.

How many indications are still untested in the B franchise alone? Then there will be the continuing development of K in combo after the pill is proven. That’s a lot of mice and lab space to develop a dozen indications at a time.

On top of that, there are still potential drugs untested in the company’s IP. These have been on the shelf for years waiting for partnership income, original molecules from CTIX inception as well as some promising acquired with Brilacidin.

There is a significant number of potential drugs waiting preclinical testing, and with a partnership and regular development and market income there will be new hires, should there not be a buyout.

The lab space was originally KARD Scientific, Menon’s preclinical CRO that did work for CTIX and other biopharma startups. Menon separated KARD from CTIX when he moved KARD’s work out of Beverly, and CTIX acquired the equipment and all IP along with Brilacidin.

They need the space for continuing preclinical and reformulation work on Brilacidin and Kevetrin.

The solstice is the nadir of darkness, not light. So, completing the allegory, this is its darkest hours, like IPIX’s luck is in the Arctic Circle and moving into spring and summer’s endless light.

The CEO will know at the end of the meeting those conditions and designations the FDA has approved. He will be able to report that the E-o-P 2 meeting was successful and that B-OM will advance to Phase 3. He will also be able to report such things as fast-track or any other elements of accelerated approval agreed upon. He may even be able to include any other designation accepted, but not details.

IPIX officers will walk away from the meeting with a good understanding of the outcomes, but not any final details for what the FDA will require in the final protocol.

A priority review can be granted at any time, including prior to Phase 1. That’s why the FDA states clinical evidence is not necessary, and it’s case by case. Priority review can be for all reviews including those between trials. It’s not just for a NDA or end-of-phase 3 review.

Sachets are still swish and spit. There is no change in delivery.

Why no deal yet? Um, because the best and most lucrative deal for everyone, management and shareholders, comes after Phase 2, not before.

This has been stated here dozens of times, yet the question is asked over and over.

“No reason- at all- for a deal to wait...”

How about the terms and interpretation of the fast-track that won’t be known until after FDA guidance. Doesn’t that affect the terms of any BP agreement? *

*Rhetorical question.

I thought I made it clear, there are many here who contend that a failed BTD is the death of the company and the death of B-Ozm and the death of a partnership. That’s overblown

I didn’t twist any words. And I did mention that it would add to a BP’s valuation for partnership. But, you have added something that is irrelevant to my discussion, that BTD is nowhere near as important as the posts on this board would lead anyone to believe.

B-OM is already fast track as an unmet need. BTD includes all of fast track plus intensive FDA support and continued review. Also, there is the strong possibility that B-OM as an oral rinse will receive guidance as an oral topical therapy. That in itself is a faster protocol than that for any systemic drug.

Once reported in the 10K there is no reason to report a term sheet again in a quarterly. Not reporting an active term sheet in a Q after reporting it a K is not in any way proof of its demise.

Your post is complete bullshit. The term sheet is dependent on the EoP meeting outcome. Any other view makes no business sense at all for BP. Why would any BP cancel a term sheet before FDA guidance? Why would Leo PR a BTD going into or during Thanksgiving week?

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.

Leo would have to be a moron to PR BTD during Thanksgiving week when few eyes are on the market other than those watching and reacting to a major correction. Best to PR next week, if the BTD is approved.

Do we know the severity of UP for each patient? I haven’t seen that revealed other than inclusion criteria that stated there was a global assessment involved. The b cohort could have enrolled a higher number of severe cases over all than the first and last. Also note that on the poster there is one outlier in results for each group, where a and c’s outlier had shorter time retention, while b had one outlier at >4 hours. All that can easily be explained by UP severity and accompanying damage or weakness to the colon with cohort b assigned a higher number of those patients.

If Leo paid the CRO out of his own pocket, it would have to be another loan. Then the complaint would be the CEO gave himself another sweetheart deal. There is no winning for him under the current attacks against the company. Anything and everything is twisted and spun as being wrong.

Peck is also what birds do to their food, and chickens do to each other. A “peck” on the cheek or lips is from the idea of quickly doing a pecking motion of a bird. Considering the benign nature of a peck, I doubt it’s the right word for the violence against the CEO that some suggest they want to do.

Leo has been very clear that he won’t strike a deal until after phase2. He has been consistent in that for the past 3 years. B-OM will likely be the first Phase3 drug for IPIX following a successful end-of-Phase meeting with the FDA. That should then be followed with a deal for OM if not the entire OM/IBD Brilacidin platform.

I agree that B-OM will need some type of Phase 3 or 3/4, but the sachets are not the problem. There are many standard dessicants and other substances preventing caking that need no testing other than shelf life for packaging. These are not sachets for mixing oral delivery or injection; these are sachets for mixing a mouth wash as a topical treatment.

Whether or not the FDA assigns BTD to B-OM, it falls under an urgent, unmet need. There should be some rolling revue to approval with a phase 4 protocol written into the final study. Again, and can’t emphasize this enough, B-OM is a mouth wash that acts topically with very little systemic absorption.

It’s the definition, end-of-phase meeting, nothing “strict” about it.

It is an end-of-Phase meeting so, yes, a Phase 2/3 could be considered a successful outcome, but an FDA requirement for a second phase 2 would be an unseccessful meeting.

I don’t understand the confusion over an end-of-Phase meeting. What that means should be clear to any investor in any biopharma company.

Again, a successful end-of-phase meeting is one where a drug is allowed to advance to the next phase with guidance for the trial including subject numbers, any requirements for sub-phases.

In the case of OM that would be permission to design and submit a phase 3 trial protocol.

It’s a rinse. It’s mouth wash. It’s considered a topical application which has a lower bar provided there is evidence of very low or no systemic exposure. IPIX has already provided sufficient evidence that there is almost no Brilacidin absorption through both the OM and UP results.

Then there is the unmet critical need for both a treatment and a prevention for Oral Mucositis. There are ready pathways for directly to phase 3 under unmet need.

That’s what the end of phase meeting means. The FDA has agreed to meet with IPIX to discuss moving on to phase 3.

A successful end of phase meeting means the data was accepted for that phase level and the drug can advance to the next phase without further or repeated testing at the previous pass level. A successful end of phase for OM would mean the FDA cleared the way for phase 3 and the company may write a phase 3 study proposal and protocol based on FDA feedback.

Yet, you don’t dispute that Leo is obligated to report a change in term sheet status in the next quarter report.

Not true. The term sheet was announced. If it failed or was withdrawn Leo is obligated to report that in a quarterly filing. The lack of mention is actually evidence that it is ongoing.

Would you mind referencing where I said there would be a short bridge study for K? I think it needs context for your comment not to be misleading if I said that at all.

Phase 1b is a bridging study for Kevetrin. Healthy volunteers where much of the data simply aims to show that oral K processes the same as injected K. It’s a short study much like the on for Prurisol that showed it to be abacavir. The Phase 2b will be a true optimization trial.