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I think it's clear by their 5/26/16 pr that regardless of dosage(50mg ,100mg, or 200mg) anyone who received prurisol realized at least a 1 point improvement(using the IGA scoring system) compared to patients in the placebo arm.
from the 5/26/16 pr
"As previously released, the trial achieved its primary endpoint in patients treated with 200mg of oral Prurisol. Among patients participating in the study with the severest form of psoriasis, those having a baseline IGA score of 3 (“moderate”), the primary endpoint was met in 46.2% of patients who received Prurisol 200mg. This data was derived from analyses of all patients randomized across all 9 participating study sites.
Additional preliminary data analyses of secondary endpoints show patients who received any dose of Prurisol, regardless of the treatment arm, had a 1-point improvement (using the IGA scoring system) at a higher rate than that of patients in the placebo arm. This is another clear indication of the drug’s efficacy. Increases in Prurisol’s therapeutic response, upon evaluating patients at Day 56 (Week 8) and Day 84 (Week 12) of treatment, also were apparent in the Prurisol 200mg arm, suggesting an improving response over time.
In light of Prurisol’s greater efficacy in treating moderate psoriasis cases, the Company expects the next clinical trial of Prurisol will target patients with moderate to severe psoriasis, with an optimal dosing regimen continuing to be assessed."
All I will say is time will tell.
2/3/17(ctix (ipix)opened $1.05, closed $1.105)
"Expect the CTIX share price to more than triple by or before the end of February 2017.
Good luck and GOD bless,
George"
Beware of irrational exuberance.
Why question one who relays public info distributed by the U.S. government? I'm not too informed on short sales, but he(she) does does provide a link for scrunity and argument.
Sox040713 offers the best retort IMO, but, I'll admit, I know little of the subject(shorting).
Williamsc,
I think it was faster than that,
from 5/11/16 pr- the clinical database for the Phase 2 clinical trial of Prurisol for the treatment of mild-to-moderate chronic plaque psoriasis is expected to be “unblinded” next week.
from 5/24/16 pr-...is pleased to inform shareholders that topline data from the Company’s Phase 2 FDA trial of orally-administered Prurisol in the treatment of mild to moderate chronic plaque psoriasis have been compiled and reviewed. The trial successfully achieved its primary endpoint, further validating Prurisol’s potential as a novel oral treatment for psoriasis.
Who knows how long(or short)it takes to analyze the results, but patients returned every two weeks for evaluation of of the outcome measures(2 primary and 9 secondary, duration of measurement either 16, 12, or 4 weeks depending on what was being monitored).
Close;)
I was responsible for taste testing the blue berry muffin's at Jordan Marsh at Shopper's World.
How do know if didn't prearrange a meeting? Last day of Hanukka is today. Don't know about you, but this is the first time I've taken xmas week off since I was a senior in high school(1970's). Our office will bustle as it always does during xmas /new years. Given eveything on ipix's plate, I suspect they'll be as busy as ever.
Thanks for your response.I think many investors have considered the thoughts and concerns you conveyed. I know I have and have decided not to add given past performance.
Plan to visit Beverley, MA sometime next week during xmas vacation (on my way to Marblehead,MA to visit one of my siblings). Hoping light does't dawn on (my) Marblehead regarding my investment in ipix, and that my visit reassures my investment.
Very fair question, but somewhat opened ended.
Complete the circle which you asked- "how super cheap will shares be if
1) deal is made for B OM and P fails?
2)no deal yet for B OM and P fails?"
Follow through question to yours:
What happens to sp if:
1) deal is made for B OM and P succeeds?
2) no deal yet for B OM and P succeeds?
Never mind other questions which could be asked. Pls give us your opinion to your own questions, and my follow up questions.
Thanks
What, specifically, protocols are you referring to(which protocols prevented those in the Texas region from participating vs those in the New Hampshire region)?
Thanks
ipix announced on 8/28/17 that ph2b P was all enrolled. 16 weeks from then is 12/18/17 at which time results can be unblinded.
Ph2a P(115 patients)unblinded around 5/11/16 per pr of that date. Results released on 5/24/16.
2b has 199 patients and more outcome measures. From the trial site, "During treatment, subjects will return to the study center every 2 weeks. Efficacy assessments, including physician and patient rated endpoints, will be measured throughout the study. Safety and tolerability will be assessed by ascertainment of AEs and results of clinical laboratory testing, vital signs assessments, and need for concomitant medications."
I think it will take longer for 2b results than 2a results, guessing in terms of add'l weeks vs months.
They(IPIX) announced final tment of the last patient on 10/2/17. 4 weeks(28 days from 10/2/17) of follow-up equals 10/30/17 unblinding.
I suspect the unblinding started on time(why not?), or shortly thereafter 10/30/17.
I interpret the two words they used, "After unblinding", to mean after all unblinding is complete. Expect word any day.
She's good.
Hope you fared the recent Texas storms well. Donation drives continue up here for TX, FL,and PR.
kfc
16 weeks(112 days) from 8/28/17 is 12/18/17. I won't claim to know when they will announce results, but believe it will be well before March given the frequency of follow-up and the repeat observations made at each follow-up.
From the trial description:
"During treatment, subjects will return to the study center every 2 weeks. Efficacy assessments, including physician and patient rated endpoints, will be measured throughout the study. Safety and tolerability will be assessed by ascertainment of AEs and results of clinical laboratory testing, vital signs assessments, and need for concomitant medications.
At a subset of sites, blood samples for determination of plasma concentrations of Prurisol (abacavir glycolate) and abacavir, it's metabolite, will be obtained from subjects who consent to provide these samples. At selected sites, for those subjects consenting to photography, standardized digital photographs will be obtained for illustrative purposes."
I suspect he does because he is likely a true New Englander. (sox 040713 I'm guessing means he's a Boston Red Sox fan. The bosox won the world series in 2004(after a long drought),2007, & 2013. Wouldn't be surprised if he's made his(her?) way to Beverly once or twice- a stones throw from Bean town(Boston).
Go Sox, go Pats, go Celtics go Bruins, and good luck to Gen John Kelly(new chief of staff- Boston(Brighton) native.
Pears,
Couple things.
1. My Trump reference was tongue in cheek.
2. Trump has not much time to study. Spends too much time on twitter or at Mar-Lago.
3.Agree with your assessment about detailed bead data/fda approval. The ONLY wiggle I can give ctso is that they believe EU, India et al offers a larger market than USA at much a much lower priced proving ground.
4. A friend of mine worked as a salesman for a Massachusetts company called Cytyc(Boxboro, MA). They invented a system called Thin Prep, which was designed to replace the pap smear.
At a 4th of July party sometime in the mid 1990's, he called me to his car, opened the trunk and pulled out a thin prep package and explained the concept. He explained his job was to advise doctors of it's potential. Even after it's later approval, it was a long slog before thin prep became the dominant screener for cervical cancer(soc). They were bought out by Hologic in 2007 for over 6B dollarsin 2007.
So Pears, I understand your argument completely, but I also understand the potential.
Or, perhaps, Trump could issue an executive order requiring cytosorb treatment to be an OPTION.
I sense they have a better prognosis now than they did earlier today so I'm likely barking up a tree.
But.....
Hopefully, the Yale-educated/Harvard residency(Beth Israel Deaconess) Dr Chan has the sense to pick up the phone and offer Cytosorb to the doctors at MedStar Washington Hospital Center, where House Majority Whip Steve Scalise lies in critical condition due to, among other things, some organ failure.
If they say no thanks, fed-ex a few anyhow.
http://www.msn.com/en-us/news/us/why-a-single-gunshot-to-steve-scalise%E2%80%99s-hip-could-be-life-threatening/ar-BBCJFkY?li=BBnb7Kz
My bad, baking powder not baking soda.
Red Cabbage-
Red cabbage is the most common natural blue food coloring here in the States. Cooked red cabbage leaves will eventually turn bluish purple if soaked in a slightly basic solution. To make a blue food dye, slice up red cabbage leaves and boil for 10-15 minutes. Strain out the cabbage, reduce the liquid until it is thick and syrupy (the cooking liquid from a whole cabbage will reduce to about a quarter of a cup. Now you have an intensely purple syrup. Add just the tiniest pinch of baking powder (you really have to go slowly here or you can turn the whole batch green). Keep adding baking soda in very small amounts until the color just turns blue. It is important to add only enough baking soda not only for the color, but for the flavor. Small amounts of baking soda have a negligible effect on taste, but add to much and it will taste terrible. Now you have a blue dye, As unappetizing as boiled cabbage and baking soda sounds, the flavor of the dye really is not that pronounced. Use it with a light touch to add blue to icings, cake batters and cookies. but remember that the color can still change. If you add it to an acidic food, it will go right back to purple.
Nice, but that's nothing compared to the 185,676 shares that were granted to Bloch(48513), Capponi(53838), Chan(59325), and 6000 shares each to the stellar directors (M(Master?)Bator,J.E.Raymond,A. Kraus,A. Sobel) on 2/24/17.
Never mind the hand outs all the other years to the same people.
Njtc Investment Fund, L.P., ????
Interesting, thanks for the post.
From your attachment:
"....
The day almost always goes the same in terms of agenda. The sponsor makes out their case and presents it. ....."
From IPCI's most recent presentation(one week ago):
".....
the strong case for REXISTA
First to declare bioequivalence to the reference drug(OxyContin)
First Oxycodone XR to demonstrate no food effect(Cmax and AUC)
First to DEVELOP a blue dye that may flag early abuse or misuse
....."
Blue dye can be made many ways including combining red cabbage, water, and baking soda.
Food for thought.
I do not think they will have much to add to the mod to severe trial(though they could, depending on any uptake of enrollment).
Start date: 10/2016
1st enrollment release: 11/9/2016- 8 sites recruiting
2nd enrollment release: 12/12/2016- 23 sites recruiting
3rd enrollment release: 01/30/20170- 25 sites recruiting
4th enrollment release: 03/28/2017- 28 sites recruiting(70% enrolled/pre-screened)
5th enrollment release: 05/09/2017- 29 sites recruiting
6th enrollment release: 05/26/2017- 30 sites recruiting
7th enrollment release: 05/30/20170-31 sites recruiting
Time shall tell.
BIM will buy further, boatloads, when/if the price declines. Buying now.
Thanks
Agree. His(her?) argument is that IPCI's Rexista w blue dye#1 will kill more people than Purdue's Oxycontin ALREADY has, and at a higher mortality rate.
I highly doubt it, he(she) either has some other agenda, or does not grasp the concept of preventive maintenance.
correction,.1mg/kg=.0454mg/lb
I found this on wiki:
The following legal limits apply in the EU (E 131) and other countries: 150–300 mg/kg depending on the type of food. Safety limit for foods and drugs: 0.1 mg/day per kg body weight.[9] The ADI for Brilliant Blue FCF is 6 mg/kg."
ADI is acceptable daily intake.
1mg/kg= .0454mg/lb
Thx Samsa. Will the one attorney not with ATU (she's with Smith, Katzenstein & Jenkins LLP out of Delaware) argue the case should it go to court since she's registered with the Delaware Bar?
Can a lawyer who is not registered in a state where a trial occurs actively partake(ie speak) at the trial?
Who is the new attorney, and from what firm? I'm guessing a Delaware firm.
Thx
Or perhaps they structure a deal with Amin Talati Upadhye(ATU) via some cash but the majority of costs in shares? The 3 attornies representing ipci from ATU (Upadhye, Cwik, and Tang) have impressive resumes.
"Although many of our attorneys are trained scientists, we also leverage our extensive business law experience to help clients realize the full value of their intellectual property rights.....
For example, Amin Talati Upadhye lawyers acted as lead trial counsel in the groundbreaking case Merck & CIE, et al. v. Gnosis S.p.A., et al. where they achieved the first successful invalidation of several pharmaceutical patents through the new IPR process. This matter was also significant as it was the first time the Federal Circuit affirmed the Patent Trial and Appeal Board’s invalidation of a pharmaceutical patent in the new IPR process."
Cwik was lead attorney, Merck lost.
I think the real brain trust of these 3 will be Tang and Upadhye, and Cwik will summarize their findings.
The 4th attorney, an attorney, employed with another law firm out of Delaware, I haven't checked out.
Upadhye-As the former chief in-house counsel at three leading pharmaceutical companies, he is known for spearheading innovative business and legal strategies to protect an existing drug’s patent – or challenge those of a competitor. A prolific writer and frequent speaker, Shashank is the author of numerous articles and the leading treatise on navigating complex U.S. laws of FDA brand/generic drug development: Generic Pharmaceutical Patent & FDA Law, now in its 10th Edition (2016).
Tang- Yixin Tang combines a creative and assertive litigation style with a superb technical training in his legal practice focusing on intellectual property litigations.
...He has fine-tuned his practice to adapt to the various business, regulatory, and legal needs the clients may have. He has the ability to understand quickly the big picture as well as specific issues in the case, develop an efficient and effective litigation strategy from the start, and form and lead a team to execute the plan. Yixin is particularly adept at gaining insights into expert witnesses’ various technical expertise, understanding how the experts’ expertise fits into the legal strategy, and formulating strong arguments that are both legally and technically sound. More important, Yixin understands that the clients’ needs and concerns go beyond the particular litigation proceeding at hand, and has had extensive experience advising clients in developing and achieving their goals.
Prior to attending Harvard Law School, Yixin obtained a Ph.D. in Molecular Biology and Microbiology from Tufts University, taught microbiology at Brandeis University, and underwent post-doctoral training at the Whitehead Institute for Biomedical Research in Cambridge, Massachusetts. Yixin’s research interests involved plasmid vector engineering, microbe-host interactions and microbial pathogenesis, vertebrate embryonic development and the regulation of genes involved in signal transduction.
Yixin is an avid duplicate bridge player and competes frequently in national and regional tournaments. He enjoys travelling with his family to off-the-beaten-path locations all over the world.
The Whitehead Institute was founded by Jack Whitehead and MIT. Tang is no dope.
IPCI has 3 lawyers working out of Chicago and one out of Delaware. Purdue has 7 lawyers working out of New York, one out of Chicago, and one out of Delaware. Jones Day seems very politically connected(via the attornies they've hired(past politicians)). Hopefully ATU does not give the Jones Day shark out of Chicago the time of day. I expect Jones Day to bamboozle ipci with tons of paperwork.
Brains(ATU,IPCI) usually send Brawn(Jones Day,Purdue) home with the tale between their legs.
The 4 lawyers defending ipci due to the rexista suit won't be cheap. At least we don't have 9 sharks on the case like purdue.
I pretty much used the hi's and low's within the time. Appreciate your reply, and acknowledge the reason for them.
Not sure, but have begun to believe that Chan believes proving things in the USA can be expensive and, knowing their device(cytosorb), where they have obtained approval outside USA, and where they see a larger market than USA, why not concentrate in Europe(and elsewhere where they are accepted).
They do have some small studies in the USA, but it looks, sometimes to me, that they are trying to break the fda, and force them to acknowledge, based on studies beyond FDA's boundries, to admit Cytosorbents has something.
Based on past course, either ctso or fda is likely to be rendered foolish.
At this point in time, I believe the fda shall be rendered as fools.
Definetly not content with the sp- down ~74% in 26 months($15.24 to $3.95), but in 26 months+-they have increased their quarterly revenue by ~330%(723k to 3.11M). Though the last earnings showed a loss of 5 cents/sh, 26 months ago it was a loss of 37 cents/sh. All numbers except for sp are improving.
June 1st will mark the start of the 3rd quarter for ipci as 2nd quarter ends a week from this Wednesday(5/31/17).
I'm not a lawyer, but the 2010 link provided seems to spell things out. Their response to purdue says they are willing to get into a cat fight. Wouldn't be surprised if they(IPCI) have garnered some monetary backing.
21 days started with icpi's response(I haven't that date, guessing 5/17/17 +-). If you read the link, the defendant can request an extension to respond, 30 days I think, not sure if the plaintiff is afforded a 30 day extention request.
"how many days for the purdue lawyers to respond? does judge need to tell them to respond by a date or is it automatic?"
Found the notes below at
http://iposgoode.ca/TheUSPatentLitigationProcess-IPOsgoodeDecember2010.pdf
pg 4, 2nd paragraph:
If the defendant has asserted counterclaims (e.g.,
asserting that the plaintiff’s patent is invalid), the
plaintiff must serve a reply, which is the plaintiff’s
answer to the counterclaims. The plaintiff is
required to respond to counterclaims in the same
manner as the defendant is required to respond to the
plaintiff’s claims—that is, by either denying or
admitting the allegations. Replies are due within 21
days after being served with the counterclaims.
Authored in Dec 2010 by:
Irfan A. Lateef is a Partner at Knobbe Martens in
Irvine, California. He is a graduate of Georgetown
University Law Center (J.D.), Northwestern
University (M.S. Biomedical Engineering), and
University of Illinois, Urbana-Champaign
(B.S.E.E.).
Marko R. Zoretic is a Partner at Knobbe Martens in
Irvine, California and is the president of the
Canadian American Bar Association. He is a
graduate of McMaster University (Electrical
Engineering and Management) in Hamilton, Ontario
and Osgoode Hall Law School (J.D.) in Toronto,
Ontario.
Don't know how much(if at all) things have changed since 2010.
Pg 7 of their paper notes "If a patent infringement lawsuit makes it to trial—and less than 5% do—it will likely be a trial
by jury. The parties may waive the right to a jury
trial and have the court try the case, but such waivers
are rare."
oseph E. Cwik has joined Amin Talati & Upadhye, Chicago, IL, as a new member and will focus on areas of business and intellectual property litigation.
A trial lawyer with significant civil litigation experience, Mr. Cwik has represented numerous clients in disputes involving patents related to pharmaceuticals, dietary supplements, and medical foods. He also represents clients in patent infringement actions involving abbreviated new drug applications filed with the Food and Drug Administration. Representative drugs involved have included Treanda, Pradaxa, Fosamax, Patanol and Cymbalta. Mr. Cwik’s business litigation experience includes prosecuting and defending numerous state and federal business claims involving the False Claims Act, breach of contract, fraud, replevin, anti-kickback statutes and tortious interference.
Cwik was lead counsel that recently defended an API supplier to a generic pharmaceutical company and forced the brand drug company to withdraw all patent infringement claims against his client resulting in a final termination of the ITC investigation. Later, he challenged the validity of four of those same patents in inter parties review ("IPR") proceedings before the Patent Trial and Appeal Board. In its final written decisions, the Patent Office agreed with his client and held that all 58 out of the 58 challenged claims were invalid or cancelled. These decisions represent the first time a party has successfully defeated a pharma-type patent through the new IPR process. Mr. Cwik also successfully defended on appeal a trial court’s ruling that a patent concerning dietary supplements was invalid.
“Joe has been repeatedly recognized as an Illinois Super Lawyer in the area of intellectual property litigation in 2010, 2012, 2014 and 2015,” said Amin Talati & Upadhye member Rakesh Amin. “We’re delighted to have him on board.”
Makes sense, the mild to moderate study enrolled 115 patients at 9 sites in 8 to 9 months.
115pts/9months/9 sites)= 1.42 pts/month per site. What should be mentioned is that 80% of cases are mild to moderate, while 20% fall into the moderate to severe.
CTIX has designed the study such that of 189 patients, 81 pts(42.9%) will receive placebo, 81 pts(42.9%) will receive the 300 mg daily dose(150 mg twice/day), and 27 pts(14.2%) will receive 400mg daily(200mg twice/day).
If the severe cases get the higher dosage of 400mg daily, then an enrollment rate of approximately 1.5 pts/month per location is feasible.
https://www.aad.org/media/stats/conditions/psoriasis
Karen,
"The Kevetrin phI at Dana Farber didn't focus on any one cancer."
Correct, it focused on solid tumors(tumors are known to show up throughout different locations in the body). I believe they choose the ph 2 target(Ovarian cancer) based on results of ph 1 trial.
A matter of probabilities, and statistics, I would think is why they have focused on OC.
Don't know why Dana Farber(DF) is no longer involved, could be a number of reasons. Did a check of DF Ovarian cancer studies and found 101 of them, appears 50 of them are still open.
I do find it curious as to why ctix has not specifically identified the site doing the ph 2 in Dallas(no problem identifying the phase 1 participants(with names) in Boston. I was hoping ph 2 was MD Anderson, but they appear to be based out of Houston, not Dallas.
Perhaps DF could not accommodate ctix's requested schedule(the ph 2 is scheduled for less than a year and is specific to ovarian cancer, while ph1 was solid tumors and took nearly 4 years. Ph 2 is also only 10 patients while ph 1 was 48.)
The company is obligated to answer all questions.
BMO added 106,957 shares in the 1st qtr(p.e 3/31/17(a 16,179.6% increase)) Deutsche Bank added another 65,027 in the 4th qtr(p.e 12/31/16). Acrospire Investment management more than doubled their holdings in the 1st qtr.
Those reporting in the 1st qtr:
Increased shares: 112,077 shares
Decreased shares: 3,897 shares
Increase/decrease ratio= 28.76/1
Good post.
From the most recent 10k:
pg 14, 2nd paragraph:
There are generally three categories of sepsis, including mild to moderate sepsis, severe sepsis and septic shock. Mild to moderate sepsis typically occurs with an infection that is responsive to antibiotics or antiviral medication. An example is a patient with self-limiting influenza or a treatable community acquired pneumonia. Mortality is generally very low. Severe sepsis is sepsis with evidence of organ dysfunction. An example is a patient who develops respiratory failure due to a severe pneumonia and requires mechanical ventilation in the ICU. Severe sepsis has a mortality rate of approximately 25% to 35%. Septic shock, or severe sepsis with low blood pressure that is not responsive to fluid resuscitation, is the most serious form of sepsis with an expected mortality in excess of 40% to 50%.
pg 14, 4th paragraph:
The only treatment that had been approved to treat sepsis in the U.S. or EU was Xigris from Eli Lilly. Because of concerns of cost, limited efficacy, and potentially dangerous side effects including the increased risk of fatal bleeding events such as intracranial bleeding for those at risk, and also because of problems with reimbursement, worldwide sales of Xigris decreased from $160M in 2009 to $104M in 2010. In October 2011, following its PROWESS SHOCK trial that demonstrated no benefit in mortality in septic shock patients, Lilly voluntarily withdrew Xigris from all markets worldwide, and is no longer available as a treatment.
pg 15, 1st para: Development of most other experimental therapies has been discontinued, including Eritoran from Eisai, CytoFab from BTG/AstrWe a Zeneca, Talactoferrin from Agennix, and others.
pg16, para 1&2:
We estimate that the market potential in Europe for our products is larger than that in the U.S. For example, in the U.S. and Europe, there are an estimated one million and 1.5 million new cases, respectively, of severe sepsis and septic shock annually. In Germany alone, according to the German Sepsis Society, there are approximately 154,000 cases of severe sepsis each year. Germany is the largest medical device market in Europe and the third largest in the world.
Sepsis patients are treated in the ICU for 12 to 18 days on average and for a total of 20 to 25 days in the hospital. A typical severe sepsis or septic shock patient in the U.S. costs approximately $45,000 to $60,000 to treat without using CytoSorb. CytoSorb therapy for sepsis typically costs in the range of $1,000 to $5,000, depending on the number of treatments. The goal of therapy is to not only improve clinical outcomes, but to also reduce the severity of illness and reduce the need for costly ICU care (estimated at approximately $4,300 per day in the ICU). The cost of CytoSorb therapy represents a fraction of what is currently spent on the treatment of patients with sepsis and would be cost-effective if it decreased ICU stay by one to two days. Based upon this price point, the total addressable market for CytoSorb for the treatment of sepsis in the U.S. and EU is approximately $6 billion to $8 billion.