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I didn’t say it means nothing. I said it’s not what you claim. Is it important? It can excellerate the path to approval and cut the time as much as by half. But, no BTD does not kill B-OM. It does not kill IPIX.
Completely fabricated nonsense. BTD is not a binary event. Also, what momentum? Momo is neither up nor down. No momo, just sideways cause no BTD is already priced in. Also, no announcement just means more sideways unless a few idiots actually buy into a fabricated-out-of-thin rear binary.
So, are you disagreeing with what I said, BTD is not a binary event? Because that was my point.
However, I totally disagree with your contention that Leo would just automatically PR in the next 24 hour cycle.
Creating an artificial deadline around a non-binary event. First, Leo is under no obligation to PR the BTD the day after he receives notice. It makes more sense to hold off until he and other management fully analyze and understand its fullest meaning, perhaps a week or two. Second, the lack of BTD doesn’t mean the inability to move into Phase 3. It only means the FDA will not be as intensely involved in the study.
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.
A BTD, if granted, will be used to inform the end of trial meeting and the outcome. Of course the BTD decision will precede the end of trial meeting. See https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144419795
IPIX email: This morning the Company reported the following information to the UNITED STATES SECURITIES AND EXCHANGE COMMISSION on a Form 8-K.
Item 7.01 Regulation FD Disclosure.
On October 23, 2018, Innovation Pharmaceuticals Inc. (the “Company”) was informed by the U.S. Food and Drug Administration (“FDA”) that the Company’s request for an End of Phase 2 meeting regarding the Company’s oral mucositis program was granted. The meeting is scheduled for later this quarter and is focused on obtaining FDA’s guidance about the Company’s proposed development plan and review of the Company’s clinical trial of Brilacidin for the indication of decreasing the incidence of severe oral mucositis in head and neck cancer patients receiving chemoradiation.
It’s nothing of the kind. It is the next step following completion of all data analysis. The meeting covers what the FDA wants to see as a following trial: expanded safety, more absorption and systemic exposure information, more pharmakinetics, etc. All requirements and suggestions for the next trial design. None of this has anything to do with whether or not UPIX plans to go it alone. It does mean that any deal for OM is likely to be struck after the FDA meeting.
In other words, your post is bullshit.
A little light reading for your analysis for why it’s taken so much time for the submission. Below is a list of topics for discussion that must be prepared. Data is much more extensive than just efficacy against an disease without current treatment:
MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 6025.6
ATTACHMENT 1: Possible Discussion Topics for the Initial Comprehensive Multidisciplinary Breakthrough Therapy Type B Meeting
The following are possible discussion topics for the initial comprehensive multidisciplinary breakthrough therapy Type B meeting depending on the therapeutic area, development phase, and specific development program issues.
General and/or Regulatory
? The planned target date for NDA/BLA submission, including plans for rolling review
? The specific indication that studies are intended to support
? Other indications in development
? Expanded access plans, including the intent to communicate these plans publicly
? Plans to seek accelerated approval
? Regulatory status with non-U.S. regulatory agencies
? Plans to defer or waive specific studies (e.g., pediatric studies), including those to be conducted as postmarketing requirements/postmarketing commitments
? Critical aspects of proposed studies, including enrichment designs, noninferiority designs, and historical controls, and any planned novel approaches
? Plans for submission of a proprietary name request
? If a drug/device combination product, the device development information and plan
? If the use of the drug will require a diagnostic test, the in vitro diagnostic development plan with the Center for Devices and Radiological Health (CDRH)
? The Gantt chart of the development timeline
? The proposed communication plan for managing interactions between CDER and the
sponsor, including the timing and format of these interactions
Clinical and Statistical
? Existing and planned clinical sites and accrual data ? Efficacy:
? The status of all clinical trials and topline summary results
? The preliminary evidence of effectiveness
? The planned or completed clinical trials intended to support effectiveness including:
? The overall trial design, the population to be studied, trial size, proposed indications, endpoints, power, plans for interim analyses, plans for resizing of trials or any other adaptation, type I error control, and expected initiation and completion dates.
? The validity of the outcomes and endpoints. If using patient-reported outcomes or surrogate endpoints, support for those endpoints or plans to support or validate them, as necessary.
? Safety:
? Potential safety issues identified in nonclinical studies and early clinical trials
? Liver, kidney, cardiac, immune suppression, carcinogenicity, genotoxicity, reproductive and developmental, and immunogenicity safety profiles
? The clinical trial safety monitoring plan for safety signals identified in nonclinical studies and early clinical trials, and for postmarketing drug safety and surveillance (pharmacovigilance)
? The proposed size of the safety population
? The plan or the need for long-term safety studies or trials
? Preapproval ? Postapproval
? The plans to mitigate or minimize risk, proposed risk evaluation and mitigation strategies, if needed
? The proposed pediatric development plan with outlines and synopses of additional studies
Clinical Pharmacology and Pharmacokinetics
? The justification for all dose selections, including number of doses and dose intervals and a discussion of all clinical trials that will provide dose-response information.
? Specific populations:
? The dose, trial design, efficacy endpoints, size and composition of the population,
and additional safety trials for populations such as:
? Elderly patients
? Pediatric patients
? Hepatically and renally impaired patients
? The clinical pharmacology, pharmacodynamic, and pharmacokinetic trials: completed, ongoing, planned, and requests for deferral
? Immunogenicity assessments
? Dosing information from pharmacodynamics studies
? Single ascending dose
? Multiple ascending dose ? Dose response study
? Food-effect
? Drug-drug interactions (DDI)
? Thorough QT/QTc
? Pharmacokinetic studies in patients with renal or hepatic dysfunction
? Pharmacogenomics
? The plans for an in vivo bridging trial of the formulation studied in the clinical development program to the to-be-marketed formulation
? The plans for conducting population pharmacokinetics, exposure-response modeling and simulation analyses
? The plans to describe dose modifications in labeling based on DDI, age, organ impairment, among others
Nonclinical Pharmacology, Pharmacokinetics, and Toxicology
? The nonclinical studies completed, ongoing, and planned, including the number and sex of animals per dose, doses, route of administration, toxicities, duration of study, and study results. For planned studies, the timelines for initiation and submission of study reports. Examples of such studies include:
? Subacute and chronic toxicology and associated toxicokinetics
? Genetic toxicology
? Reproductive and developmental toxicology
? Carcinogenicity studies
? Animal models of disease and pharmacokinetic parameters associated with efficacy
? Evidence of mechanism of action
? Absorption, distribution, metabolism, and excretion
? Safety pharmacology, where appropriate
Chemistry, Manufacturing, and Controls
? Drug product:
? The dosage form
? The formulation description
? Administration instructions, delivery systems (e.g., vials, prefilled syringes) proposed draft packaging, and disposal instructions
? Critical quality attributes
? The control and stability strategies
? The proposed shelf life and required stability studies
? Drug substance:
? Characterization
? Critical quality attributes
? The control and stability strategies
? The proposed shelf life or retest period and required stability studies
? Proposed commercial processes:
? The manufacturing process, in-process controls, scale-up plans
? A comparison of the proposed commercial manufacturing process to the clinical manufacturing process
? Comparability of lots used in clinical trials and commercial lots or a plan to establish analytical comparability
? The current manufacturing site(s) and proposed commercial site(s), if different, registration numbers, readiness, and manufacturing timelines
? The current release and stability testing site(s) and proposed commercial testing site(s), if different
? The anticipated market demand at launch ? Proposed validation approaches:
? The drug substance and drug product manufacturing process
? Microbial control and sterility assurance
? Viral clearance
? The analytical methods
There was not sufficient data to file a BTD request for OM or UP prior to the two proof of concept trials. That was my point. Your bolded text—“FDA expects that such evidence generally would be derived from phase 1 or 2 trials. Nonclinical information could support the clinical evidence of drug activity”—can’t be emphasized enough.
Benefits diminish after approval of phase 3. There are still many options for acceleration that apply to phase 3, but need to be addressed during the end-of-phase 2 meeting to be included in a Phase 3 trial design. Again, “ideally” the BTD is submitted before the end-of-Phase 2. For example both OM and UP had one human data prior to the small Phase 2 trials. If a BTD is approved, the FDA is unlikely to require another phase 2 as it would without a BTD, as the FDA is also likely to shorten Phase 3 to a single smaller trial, as it is likely to do with a BTD in place. Still lots of benefits.
You are misinterpreting the purpose of a BTD. Ideally it is before the end of phase 2 meeting because there is little or no benefit from a BTD approval once phase 3 is approved to start. An approved BTD after the end of phase 2 meeting would require a new meeting and resubmission of the trial design, thus eating any time advantage gained by a BTD.
The BTD request is filed before the end of phase 2 meeting (ideally, not requisite). It’s not required to file before end of phase 2. How can a sponsor file a BTD before data is in and fully analyzed? Indeed, an advanced reading comprehension test.
From the last paragraph: “Ideally, a Breakthrough Therapy designation request should be received by FDA no later than the end-of-phase-2 meetings...” (emphasis mine)
Brilacidin as a Novel Inhibitor of Phosphodiesterase 4 (PDE4) Supports its Potential to Treat Autoimmune and Inflammatory Diseases; Company Invited to Present at Upcoming Crohn’s & Colitis Foundation Conference
BEVERLY, Mass., Oct. 12, 2018 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals, (IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to provide this update on Brilacidin as a novel inhibitor of Phosphodiesterase 4 (PDE4), an important aspect of its mechanism of action. PDE4 inhibitors, such as apremilast and crisaborole—the latter having been acquired by Pfizer in 2016 from Anacor—for dermatological conditions, are a well-established and actively marketed class of drugs used to treat a variety of autoimmune and inflammatory diseases. PDE4 inhibition is being studied as a novel therapeutic avenue in treating Inflammatory Bowel Disease (IBD).
Brilacidin’s Inhibition of PDE4
Due to multiple immunoregulatory functions, defensins—small antimicrobial peptides widely expressed and produced in skin and mucosal surfaces, as well as in neutrophils—play a critical role in mediating human health and disease. Brilacidin, the design of which was modeled on defensins, has been shown to be a potent regulator of immune response (data on file). It suppresses various pro-inflammatory mediators (e.g., TNF-a, IL-1ß, IL-8, IL-6, MMP-9, MCP-1). One potentially central aspect of Brilacidin’s mechanism of action concerns its modulation of the cyclic adenosine monophosphate (cAMP) pathway, an established therapeutic target, through its ability to inhibit Phosphodiesterase 4 (PDE4) as well as Phosphodiesterase 3 (PDE3).
In more detail, pre-clinical studies have demonstrated that Brilacidin inhibits PDE4B2 and PDE3A in vitro, in a dose dependent manner. Brilacidin demonstrated similar IC50 values against both PDE4 (biochemical) and cytokine release in cell-based assays, suggesting Brilacidin has good cell membrane permeability. Localized clinical administration enables Brilacidin concentrations that markedly exceed in vitro IC50 values, and, consequently, provides for increased concentrations of cAMP.
The overall effect of Brilacidin’s ability to modulate cAMP levels—complementing other aspects of its broad immunomodulatory profile—supports its potential to treat a number of chronic, autoimmune and inflammatory diseases related to issues of innate immunity, such as: IBD, atopic dermatitis, and others.
While Brilacidin inhibition of PDE4, similar to multiple established FDA-approved drugs, contributes to its therapeutic potential, its pleiotropic actions likely offer additional unique advantages beneficial to multiple clinical applications.
Brilacidin for Inflammatory Bowel Disease
Reflective of Brilacidin’s treatment potential in IBD, the drug candidate has successfully been tested in a proof-of-concept study in distal colitis. Trial results showed that a majority of patients treated with Brilacidin achieved clinical remission, including mucosal healing as evidenced by endoscopic review. Plans include developing Brilacidin in an oral dosage form to treat more complex cases of IBD, such as Ulcerative Colitis and Crohn’s Disease.
As released previously, the Company has been asked, by invitation-only, to present at an upcoming IBD conference—“IBD Innovate 2018”—hosted by the Crohn’s & Colitis Foundation and scheduled for November 13, 2018. The scientific poster—titled “Brilacidin for Inflammatory Bowel Disease: A Novel, Non-Corticosteroid, Non-Biologic Drug Candidate in Clinical Development”—to be presented at the conference will be available in the Events and Presentationssection of the Company website on November 13, 2018.
Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals, commented, “The results from our completed distal colitis study suggest Brilacidin could emerge as a novel, non-corticosteroid, and non-biologic, treatment for more extensive forms of bowel disease. We look forward to highlighting our data and sharing program insights at the IBD Innovate 2018 conference, attended by GI experts and pharmaceutical industry representatives.”
Linked below is additional information, published in a blog on the Company’s website, elaborating on how Brilacidin—given its unique and broad mechanism of action—is a promising candidate for continuing IBD drug development.
“Deficient Defensins and Missing Mucins in the Pathogenesis of Inflammatory Bowel Disease”
http://www.ipharminc.com/new-blog/2017/10/24/deficient-defensins-and-missing-mucins-in-the-pathogenesis-of-inflammatory-bowel-disease
To anyone paying attention, Menon has been mostly sidelined since his accident. This includes a reduction in both salary and responsibility. The current change only warranted an 8K filing and not a PR. And, as LR pointed out, the termination was only as an officer and employee, since he is still entangled in IPIX including sitting as a director.
Do mean that you are comparing your plans to Leo’s, and your plans never get done? So, you actually have no meetings, your laundry is always dirty as is your bike, and you never have coffee beans? Somehow I think your planning results in something more, as does IPIX’s.
“I 'plan to have meetings' all the time. I also 'plan to do the laundry', 'plan to clean my bike', 'plan to remember to get more coffee beans from the store' etc, yet somehow randomly they don't always seem to actually happen?”
This is the fiction I was talking about in the previous post: pretending guidance and estimated completion dates are firm deadlines.
You have absolutely no evidence that it will or that it is even a possibility to happen other than some fiction about the CEO’s reputation.
So, can’t wait a lousy 19 days?
OK, I get it. Let’s malign him before his time line expires. Let’s pretend he broke promises and his guidances were stated previously as hard dates for completion.
Let’s continue the charade of misrepresentation and vilification of someone who has taken a company from truly near bankruptcy and no trials to 3 platforms entering advanced trials and the cusp of partnerships.
Better question, why can’t the wise investors wait 19 more days (and the end of high holidays) to see if the CEO strikes a deal?
In biopharma, past performance is always a predictor for future performance, even when meeting key milestones. What a joke post.
My prediction, many will have egg on their faces within the next 20 days, including those currently walking back 7 straight years of vitriol.
Unless IPIX management files NT-10K (Form12b-25), which extends the filing date up to 15 calendar days after the due date of the 10K.
“If the conditions of the Rule are met, filing the Form 12b-25 gives the issuer 15 additional calendar days to file a late annual report and five additional calendar days to file a late quarterly report. Moreover, if the report (or the incomplete portion) is actually filed within the 15-day or five-day grace period, the report is deemed to have been timely filed.” —http://www.mbbp.com/news/annual-report-deadlines
The trial was a proof of concept clinical trial after preclinical work indicated B might be effective against human IBDs. It was designed to be nothing more and nothing less. That it very effectively treated (clinical remission) 10 of 17 may not be “statistically significant” due to conceptual trial design, but it is quite remarkable. Likewise, that each cohort showed increased efficacy with increased exposure to Brilacidin adds to any reliability of results.
To conclude no one is interested flies in the face of 17 out of 17 responding to Brilacidin exposure and 10 of 17 had clinical remission. This in an area with no effective treatment.
No news tomorrow only means a holy day for an observing CEO. It means nothing else.
Only a week ago a price decline was given as evidence of trial failure; this week a 41% increase in price is ignored as meaningless.
Once again, the lack of evidence IS NOT EVIDENCE!
The point was they were not pump and dump and SA required positive articles to be “balanced” while hit pieces could be packed full of lies and half-truths. So hit pieces, OK; informative articles “balanced.”
Actually, no, if you are implying SA published P&D articles for IPIX. The 6 year record shows exactly the opposite. SA published short and distort articles, and in fact, some positive articles were submitted that SA refused to publish because the articles lacked balance and were too positive. This despite that the articles were written to address attack articles full of lies, half-truths and misstatements.
So, no, no familiarity over here in IPIXland. You must be thinking of Sledland.
You don’t think that presenting at an IBD conference doesn’t put pressure on a CDA holder to close the deal for the entire platform before they present? That’s the way I read it, but I’m a glass half Kevetrin bad guy.
While Phase 1 and 2 trials for K included efficacy outcomes, K was never intended as a stand alone drug. The idea behind a p53 modulator is as a combination to enhance or add to efficacy of cancer drugs.
You are a shareholder? Leo’s interest is your interest and mine. We are all shareholders. His protecting his share value is protecting our share value. Only someone whose interest is at odds with Leo’s would think otherwise.
Whatever happens or happened, we will know once the next 10k is filed in the next week to 12 days. But, all in all, I think it’s safe to assume Leo has worked out all contingencies.
Without a space to conduct business, whatever form that business morphs into, the price collapses and Leo is out millions if not 10s of millions. Without a license agreement, at least 1, Leo needs a lab and office area to continue drug development. Even if he goes to expensive outsourcing, he at least needs a central office area. There’s more, but I won’t belabor the point. It’s just that I think it’s safe to assume Leo has worked out how to best protect his, Menon’s, Aspire’s and Aruda’s share value.
The lease states that there is an automatic extension if one of the two parties do not inform the other of cancellation at least 6 months in advance. So, we should assume the lease is extended, or that Leo has had at least 6 months to work out plans for after sept 30. If extended, then the business of drug development continues at the same facility. If cancelled, then Leo has contingency plans based on outcomes following the 30th. That is, if the plan is to leave the facility then it is likely that deals will include transferring drug development to one or more licensees or buyers. In any case, all possible outcomes are covered already.
The answer is a definite “yes and no.”
I’ll be surprised if there is anything this week, a short, holiday week. Most likely the PR cycle will start after Rosh Hashanah on the 10th.
I would think he is waiting to compile all measures including the surveys. After all, there are licenses and partnerships on the line. The last thing he or we need is a half-baked primary and secondary measures with rudimentary analysis.
IMO, no news until after the end of summer holiday (this weekend), and then all 3 milestones announced within the following 3 to 4 weeks.
The day after Labor Day, no news? A shocking bit of Holmesian deduction.
This is biotech and high risk investment. IPIX is still only 5% of my investment. I can afford to lose it all. I have stated for 6 years that no one should invest more than the can afford, and if one is buying and holding one should be prepared to buy and hold. But, how is holding for 30 more days in any way a burden to anyone especially those you mention are currently underwater?
Time lines change everything. The guy I responded too had been carping about “proof of failure” for months. That one has not been here a year yet has exhibited impatience since the beginning. Well, there’s one month left on the time, let’s give it 2 weeks. A lot can happen in 2 weeks, even more in 33 days.