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Following is the into to a good article on the state of the art in IBD;
link at the bottom;
"In the last decade there have been enormous strides in our understanding of the role of gut microbiota in the aetiopathogenesis of inflammatory bowel disease (IBD). Newer molecular and genetic diagnostic tools have elucidated distinct changes in the gut microbiota in IBD patients and clarified the deficiencies of innate immunity. A link between environmental factors like diet, host immunity and the gut microbiota has been established. This review aims to enumerate these diverse strands of converging research in the last decade to outline the exciting prospects of possible personalized therapeutic interventions for patients with IBD in the coming years."
"INTRODUCTION
Inflammatory bowel disease (IBD) comprises two distinct conditions, ulcerative colitis (UC) and Crohn’s disease (CD) that are characterized by chronic relapsing inflammation of the gut in genetically susceptible individuals exposed to defined environmental risk factors[1,2]. IBD was historically considered to be a “Western” disease but in the last decade there has been a definite increase in its incidence and prevalence suggesting that it is progressively emerging as a global epidemic[3]. In the high prevalence regions the incidence of IBD has continued to rise in the past decade[4,5].
There has been a parallel rise in our understanding of the critical role of the gut microbiota in the aetiopathogenesis of IBD. This is aptly exemplified by entering the key words, “microbiota” or “microflora” and “inflammatory bowel disease” into the PubMed database. On restricting the search to the last 10 years, over 800 articles published on this subject can be retrieved as opposed to 100 articles in the decade preceding it. This radical explosion of interest has been primarily due to the advent of culture-independent techniques like next generation sequencing and metagenomics which has enabled the global assessment of the gut microbiota much more accurately and in a vastly more sophisticated manner[6,7]. The largest and perhaps the most ambitious initiative that has emerged in the last decade is the NIH sponsored Human Microbiome Project with a total budget of $115 million to study the changes of the human microbiome in health and disease[8]. It has recently led to the publication of 5177 microbial taxonomic profiles from a population of 242 healthy adults sampled at 15 or 18 body sites up to three times, with over 3.5 terabases of metagenomic sequence so far, which will serve as a comprehensive framework for future research in this field[9]."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3921503/
Current treatments for people with IBD tend to focus on decreasing or altering immune function but defining which organisms are pro-inflammatory and which ones are anti-inflammatory is important as it could potentially lead to a treatment that wipes out the pro-inflammatory ones and repopulates the intestines with anti-inflammatory ones and studies also indicate that fungus may also play a role in the condition. Brilacidin as a therapy for IBD seems to me to be at the epicenter of where current research is focused and initial results look very promising. It seems obvious that both antibiotics and probiotics would both have a place in helping restore a healthy microbiota.
I'm not an MD, but I have done a bit of research on this topic. Not surprisingly it rapidly gets a lot more complicated when you begin to dig into it. There is a lot of ongoing research relating to reduced diversity of the gut microbiota in IBD patients and whether it's a cause or an effect of IBD. The following link is a good place to start to understand the relationship;
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4281375/
BP has had the CNDA's for months, they also informed and helped design the trials. Dr. B was retained in large part for his expertise in this area.
I believe a partnership could happen much sooner than you suspect since they are not anywhere near starting from scratch and IPIX needs a deal done so.....
K is a potential block buster, and if the K-OC trial proves efficacious even though the trial is small, women diagnosed with Stage IV ovarian cancer have a five-year survival rate of only 17% it's off to the races.
With all of this potential the anticipation is at a fever pitch.
I'm curious why the recent focus on P when B-OM results are eminent, and everyone agrees B is the most versatile and potentially the most valuable drug in the pipeline. I agree it would be wonderful if P results are good enough for a capital raise one way or another as that would facilitate the further development of B and partnerships under the most advantageous terms. If B-OM results are good I don't see P's results driving down the market cap below what it is currently.
Not sure what your point is since you initially state "They could not have known, in all likelihood, at the time they chose to go ahead with P2b, that B-OM and B-UP would look so good."
IMO IPIX is undervalued based upon B alone, we get P and K for free.
Pulling up a five day chart will display the steadily declining volume from the recent price spike. just the facts, interpret them as you like.
When a stock in trending in a narrow channel, as IPIX currently is, a monkey tossing a dart has the same 50/50 chance of being right as you with your constant predictions of day to day movement. Just because you are silent when the stock moves up no one is fooled by your constant opportunistic ruminations and protestations. Reminds me of the new brokers w/o clients who randomly cold call several hundred potential clients off lead lists given by management. They 'prove' themselves to potential clients by offering a few stock picks without asking for any business. They choose different stocks for different clients and the few that hit repeatedly, based solely on random chance, are solicited using as proof of the brokers's omniscience the fact that they predicted three or four winners in a row and thus tout the returns the client missed by not taking their advice and in the first instance and buying. Obviously they eliminate the losers from their list of potential recall clients and start again with a new list of investors (suckers).
The founders of CTIX, like the founders of all new companies issued themselves some start up shares at a value of next to nothing. The day they filed their documents of incorporation the shares were worth next to nothing other than the intellectual capacity the founders brought to the table and any seed capital they contributed. I don't know of a single start up whose founders did not issue themselves initial shares. This constant drum beat about founders shares is pure BS, no more relevant than the daily short sale figures we see every day also. If you think initial shares of a start up are so valuable then why waste your time here? Logic would dictate that you file articles of incorporation and issue yourself hundreds of millions of worthless shares.
I think dilution as bantered about on this board has come for many to be synonymous with the daily value of their shares time the SP and because the SP has gone down over some periods of time they interpret that investment investment has been diminished by the issuance of new shares.
I suggest that SP times our shares and value of our investment in IPIX is not the same thing, and does not account for the progress in the clinic afforded by the issuance. For example if the SP had gone to $10 a share few would say the increase in share count diluted their investment. As we all know in small cap bio land the SP and ultimate value a company's investment in it's pipeline are often uncorrelated for long periods of time. Until they are....
Leo finds himself (we find ourselves) in a bit of a catch 22. The cost of capital is high because the SP is too low. The SP is too low because of the high cost of capital due to the fact that Aspire's business plan requires them to buy shares at a discount and sell them into the market on a regular basis thus constantly pressuring the SP.
The only way out of the paradox is to prove the true value of the pipeline, and attract BP by successfully advancing current and future trials. Successful trial can then be expected to garner the interest of BP's who will then be competing in the market place for an ownership an stake in drug(s) at the APPROPRIATE current value of future revenue streams discounted by the cost of achieving FDA marketing and anticipated time to market. The closer to market the drug is before being partnered the lower the discount applied.
Management has decided that this is most likely the lowest cost means of raising capital and off loading development costs while acquiring expertise IPIX does not have in house. If Leo and Co. were not convinced of the long term value proposition the pipeline affords they would have raised cash much sooner and at higher stock prices. Since management comprises by far the largest share holder position this choice is their best expression of confidence that they believe the trials are going to be successful.
It's really that simple, despite the daily FUD and protestations by the same few who no doubt have their own agenda.
I agree with you as even a great partnership with a big up front payment technically 'dilutes' the future revenue stream of the the asset partnered.
" IMO the word has no beneficial meaning beyond its effect of watering down earnings. Otherwise share issuances need to be measured in terms of what the company gets for them...the value of that thing in terms of the needs of the company."
CTIX did not transfer any shares to Aruda, the settlement was between Menon and Aruda exclusively and did not involve any dilution or issuance of new stock. Aruda is of course free to dispose of his stock as he chooses, and in fact has sold shares.
Form 8-K
Current Report Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 28, 2014
"The aforementioned share transfer was strictly between the personal holdings of Mr. Krishna Menon, the Menon Trust, and Aruda. No shares or royalty payments were issued by the Company."
Because Leo and co won't sell for chump change. They know the potential value of their franchise drugs and want a lot more than BP is willing to shell out until BP is as convinced as Leo. That's reality.
The relevant fact is several BP's have signed CDA's and are currently investigating B. Speculation regarding how IPIX was able to acquire B is merely intended as a negative distraction from the current reality, FUD IMO.
The word "obviously" does not make an assertion true.
Great perspective, worth repeating.
B's prominent placement in IBDnewstoday.com may have the potential to dramatically affect future trial enrollment. I wonder if Dr. B proactively disseminated the PR or if the author discovered it on his own. Either way it would seem fortuitous.
I have long held the same point of view, that Aspire's self interest is best served by opportunistically selling more shares when the price is higher and less when it's lower. One of the more astute posters here disagreed and believes (my interpretation of his post) that Aspire is more likely a long term statistically disciplined seller, only selling a relatively small portion of their position on a daily basis.
Recent price action seems to suggest that he is correct as the SP drips steadily lower to a floor (equilibrium) that brings in buyers where it holds more or less steady until until the buyers at that level become exhausted and SP drops to the next floor, or there is good news and the price moves up on substantially higher than average volume which swamps Aspire's limited selling.
We will likely never know the methods of Aspire's game plan as they seem to deliberately limit their holdings below the reporting threshold. Since the last 12 months decline has just about wiped out the substantial profit I made timing almost perfectly the run to $4.80 I believe I've learned to be a more patient investor.
Bouncing ideas around is IMO the biggest benefit of engaging is this forum.
a 7% raise on this type of volume is a great close for this stock if it can hang in there for a few more min
If IPIX performs as we expect you may want to check out the roasted rabbit, should be plenty to go around.
You can't have it both ways, when the share price was declining you have been repeatedly saying Aspire's toxic selling responsible. Now your saying Aspire is doing the opposite and driving the price up, I suppose that'so that they can pay a lot more for the next 35 million or so shares they are soon acquire in the next financing round. Makes absolutely no sense.
I don't recall exactly what the volume was when the stock approached $5, but it was in the 5 to 10 million per day range if memory serves me correctly. At any rate it was extremely liquid for a time and like you say that was retail only with no where near the pipe line they have now....
Up over 7% and volume is almost up to 30 day average, and were only half way through the day. Hope it the trend continues.
came across this regarding temporary marketing approval, FWIW;
"Clinical endpoint ‘validation trials’ that also provide biomarker data for earlier regulatory review under the FDA Accelerated Approval (AA) process.
In 1992, the US Congress created a regulatory process, often referred to as ‘accelerated approval.’ Under this process, a sponsor could receive temporary marketing approval from the FDA for a new treatment regimen that appears to address unmet needs for patients having a life threatening disease, if clinical trials establish the regimen has compelling effects on a biomarker and if such effects are ‘reasonably likely to predict clinical benefit.’ Once AA is achieved, a ‘validation trial’ must be completed in a timely manner to determine whether this new regimen truly provides meaningful benefit on clinical endpoints, i.e., on tangible measures of clinical benefit [11]. To ensure the validation trial will be completed in a timely manner after AA has been granted, a recent practice in the oncology setting has been to design trials with the dual objective of (i) providing interim data on biomarker effects that, if compelling, would be released to sponsors and FDA for consideration of AA; and (ii) serving as the ‘validation trial’ through continued enrollment and follow-up to provide a definite evaluation of effects on tangible measure(s) of clinical benefit. Recognizing that the principal evidence regarding the benefit to risk profile of the experimental regimen is obtained from the longer term second objective, early release of the biomarker data is a breach of the confidentiality principle concerning interim data that can compromise the integrity of the validation trial."
"In the setting of the Phase 2b or Phase 3 trials that are described in the Introduction, in order to reduce the risk of misleading conclusions, access to interim results on efficacy and safety of study interventions should be limited to the statistical group preparing the interim reports and to members of an independent DMC who are guided in data interpretation by proper group sequential monitoring guidelines. As asserted by Ellenberg et al. [1],
‘This principle is justified by the need to minimize the risk of widespread prejudgment of unreliable results based on limited data … this prejudgment could adversely impact rates of patient accrual, continued adherence to trial regimens, and ability to obtain unbiased and complete assessment of trial outcome measures. This prejudgment could also result in publications of early results that might be very inconsistent with final study data on the benefit-to-risk profile of the study interventions.’"
" the focus was on P...now it's all about B", therefore P must be a failure.
This argument is based on a classic informal fallacy, which occurs when the contents of an argument's stated premise fails to adequately support its proposed conclusion.
Thanks for the heads up. Very scary stuff. No way to detect and no way to prevent after exposure and you don't know you have it until it has metastasized. Unfortunately it sounds like B-OM may have a larger market than anticipated.
I agree IPIX has the positive skewness and option-like features of an asymmetric investment, I'm just not currently able to go that far out probability wise without seeing more data.
sorry it would equal gross revenues of $6.666 billion still no meant feat
IPIX is a very long way from a billion revenue let alone in earnings. If Leo inked a deal with mid teens revenue sharing that would mean B would have to generate 15 billion in sales. No small feat by any means. I suspect IPIX would be acquired long before it hit $60 a share if BP were estimating that type of market dominance. JMHO
IPIX's story is like the story of the Chinese bamboo tree:
You take a little seed, plant it, water it, and fertilize it for a whole year, and nothing happens.
The second year you water it and fertilize it, and nothing happens.
The third year you water it and fertilize it, and nothing happens. How discouraging this becomes!
The fifth year you continue to water and fertilize the seed and then---take note. Sometime during the fifth year, the Chinese bamboo tree sprouts and grows NINETY FEET IN SIX WEEKS!
This latest update seems likely to have been calculated to encourage potential partners to get serious as they are not alone, as well as to keep us informed about progress on multiple fronts. Taken as a whole UP/UPS, UC, Crohn's Disease and Brilacidin OM represents an extremely valuable platform drug for "global BP". Dr. B is marketing B via these updates as a novel, non-corticosteriod, non-biologic IBD treatment. Each trial supports the efficacy and safety profile of the entire platform and their MOA's. Formulation development plans include foam and/or gel for the treatment of UP/UPS and oral tablets for the treatment of UC and Crohn's. The soon to be released top line for OM should serve to inspire competitive interest for a potentially huge block buster of global scale.
I suspect a supplemental probiotic may go a long way in insuring the re-population of desirable gut bacteria have great advantage.
Partnerships are inevitable, this informative and exceptionally positive update indicates to me that IPIX is not pausing but is rather more committed than ever to completing existing trials in order to enlist the aid of a global player with the aid of endoscopic proof of efficacy;
“On the heels of a successful Proof-of-Concept study of Brilacidin in IBD, we look forward to continuing the Company’s momentum in this area,”
“Given IBD’s complex pathogenesis and variability in patient response to any one drug, new treatments are needed. More broadly, discussions remain ongoing with numerous global pharmaceutical companies, which, like us, see the considerable potential of Brilacidin as a multi-faceted drug candidate, with possible application across multiple therapeutic areas. The beauty of Brilacidin is that it was designed not only to mimic but actually to improve the body’s innate immune response—and that’s exactly what we’re now seeing translate into the clinic in the form of favorable patient outcomes.”
If Leo's pronouncements prove prescient the probability of a partnership increases proportionally and the share price should correspondingly reflect that.
If B-OM top line results are anything like interim results suggest, a deal and or a PIII will commence post haste, probably with BTD designation with another deal for a B version bio-film in prosthetic devices likely very soon to follow that. The same could be said for B-UP. The dominoes are lined up ready to fall, we just need one good result and a partnership to validate the platform.
The possibilities will be much more obvious to everyone following good results and our first successful deal.
I said that I sold 600k shares in the run up to the all time high. I own more now and I'm pretty much giving you my thesis in my posts. Partnerships of all stripes, big up front payments for indications or an entire platform drug following good results all the way down to partnering select foreign markets to signing up a BP for use as an adjuvant and everything in between, or even a buyout. Partnerships are likely and the investment risk is asymmetric is my thesis.
I'm suggesting that there are many potential possibilities to partner, even K as an adjuvant, this is not an all or nothing pivot point as many are implying. I suspect the future may be some combination that is difficult to predict at this moment. This company will not go out of business with all of the potential that their three platform drugs afford.