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Yeah- 3/17 PR about trial conculsion and stuff about apremilast/etc
Maybe that is a reveal
wish he said more with yest PR though
re-read last PR, nothing about partnership
Still predicting failure
Ah- missed the partnership suggestion
Must re-read
OK a guess- they have the data for P P2 and Leo has said nary an encouraging word. No slip.
Therefore my guess is not a good outcome for Prurisol since Leo tends to want to hint at positive results.
Sadly I expect no benefit from Prurisol. Hope to be proven wrong
of course agree, I was just yapping
Look we don't need a dentist either, even one with research roots-how about an oncologist or two?
hound dog chasing a car- who does not like that.
It is still very risky buying now.
Look- if Leo had added a dermatologist to the board in addition to Sonis(B-OM) and Farraye(B-UP) then I would buy
But no....
why buy now? and to risk a drop if P results not good? I do not have the nerve to buy right now-
The soft lock- well that explains it
In the next few days maybe we will get some additional PR about how the phase 2 trials for Kevetrin were mistakenly soft locked, and not just the P data sets.
K p2 freeze- that clears it right up
That's OK, right? I mean, how much progress can those T cell researchers do for solid tumors? Oh they are at work on pancreatic CA too now? Hmmm..
Maybe K can move forward ....before it is obsolete.
Seriously, I think combo with the CAR T folks and the standard chemo folks will be the way forward
But time just keeps passing
If there were a deal in the offing would we be sitting and waiting for the phase 2's to start? Would we wait for a grant application for funding with Mayo for a pancreatic ca p2 ? No, we would be moving it forward not waiting for some "maybe"grant money.
No partnership- yet
I did write to Leo with similar thoughts expressed in the post, and of course it is silly to do so, he must be desperate to get the trials in gear. I was/am in a melancholy mood after some very sad patient encounters.
But can't CTIX get the funding on its own to move forward with Mayo?
Which board concerns me less- just glad to see he is able to attract big-time actual talent for advice
Prob Farraye has been a behind the scenes advisor for B-UP for some time
Just as Sonis was bullish about B-OM after his original work with it in the hamster pouch model
I am sure that we all agree that it suggests that things must be looking good for B-OM and B-UP for these guys to get on board officially. Will the trials still fail?- eyes remain peeled
Just reading though his recent publications, trying to see where his connections are and what that might mean for the B-UP trial. Cannot tell.
But what is immed apparent is the amazingly wide scope of his interests and his publications, and from what I can tell he sounds like a prime player to have on board.
Farraye, Sonis, Trust- after naming golf pals to the board he has now attracted some real talent. Things are looking up!
I have never heard Farraye talk, though he is in Boston.
What a range of interests- picky little topics to big picture IBD stuff, hard to believe he has a minute in his schedule to spare for this new assignment, even if it takes little time
I have gone on record as identifying the start of BP3 as a pseudo catalyst, something good for a small bump at most that immed settles back down
But Brilacidin itself is an amazing story, and I hope that I will be in practice long enough to prescribe it, but I just turned 59, and we shall see. If it hits the market in 3-5 years then there is enough college tuition to be paid to keep me working
Maybe even more exciting though are the unmet areas of need for the anti-inflammatory apps of Brilacidin.
If B-OM is a big success it will be such a gift for patients and us, the shareholders(not to mention the cross-section of shareholders who might one day benefit as patients), and because its success is an unknown and Brilacidin has proven its success so far, B-OM is tantalizing. As is B-UP. And why did Leo mention Crohn's also, in prev PR when the trial is for UC? Have they done any work to suggest a benefit for Crohn's too? Clearly they have their eye on more than just the very distal colon, since as you know Crohn's involves the entire GI tract
And then there is HS and conjunctivitis and maybe the post op cataract market...
Changing the subject: Just in the last couple of days I have looked into the eyes of patients dying of ovarian cancer and pancreatic cancer, not responsive to their salvage chemo regimens, and tried to offer words of comfort. I truly hope that Kevetrin may benefit some of these patients, and I wish they would just get on with their trials, already.
You are telling me that there is no funding for a phase 2 for standard chemo plus Kevetrin for pancreatic CA at Mayo? And we are waiting for some grant we prob won't get ? Why not fund it some other way? Why not moving forward NOW? This is hard to watch, with so much happening on some fronts, but on other fronts a lull. Perhaps inevitable, but c'mon CTIX and start those phase 2 trials-
I do like this reminder that I overreacted to the single lesion call and that at least one poster- Karin CA had the good sense to say that you just have to read the trial endpoints, if you want to know the endpoints
Or maybe something a bit more formal:
Previous wannabe catalysts:
2015:
-disappearing spleen lesion KP1
-Hidradenitis suppurativa meetings with the FDA- scheduled then not scheduled, then HS trial put on hold pending B-OM info
-Bologna AML Kp2.....sigh
-Mayo pancreatic CA KP2 trial- it is so promising, and yet the funding would have to come from some grant that lots of other people are applying to also
you get the idea, right?
please, all welcome, add your own favorites
While we all sit here and wait another month for prurisol data, maybe we could look back at previous potential catalysts- you know, the short-lived catalysts that have failed to keep CTIX out of the dollar and change OTC area of the market
My favorite, as you all know, is the disappearing spleen lesion PR, where the share price climbed to nearly 5 on a report from one patient. Perhaps newbies would like to review some of those areas also, as we wait for actual share moving news
Do not worry about other non events such as P3B and P2 K ovarian trials -finally actually starting. And don't hold your breath for the really big other future non-event, the phase 1 K paper.
With B-OM(? half a year) and P(30 days or so) we will get actual news.
I thought we would hear something about B-OM with the B-UP announcement but that has come and gone. There is though still the excitement of guessing which country the B-UP trial is in
CTIX/Jorgensen update: the departure may simply be related to post lyophilization and purification fatigue- common, it must be said, even to be anticipated, and yet difficult to treat. We may never really know the reason for the departure, but the warning signs of post lyophilization syndrome should be considered. Just recall the many PR statements about brilacidin, and what must have been going on behind the scenes, behind the closed doors of science and industry, in those temperature controlled environments. And then it is all over, the revolutionary new antibiotic reduced to a pile of (stable)powder.
Little wonder indeed.
Sorry that I cannot append a lot of other stuff here- links to all the things that one can easily find on the website, for example. It is such the fashion now that one must look no farther than a couple of hours to find such compilations. What must the newbies think- obsessive compulsive due diligence info?
We need to ask ourselves, why the excitement over an article that says a lot of stuff anyone who follows the stock closely already knows? I will re read the article but the first time through it struck me s a bland recitation of the known.
Maybe it means that those who already own a lot of shares are nervous, and are happy to see someone else verify some of their hopes for the pipeline. That is all I can surmise- a big hurrah for the article based on fear that we sit here, near oblivion, with an investment of real potential.
What was new and exciting about the summary? Nothing.
Why is it stickied and fawned over then? It beats me.
Celebration over tedious regurgitation of some of the data about K and B and P?
Good grief.
What is it really all about?
Unclear if link or not, prob, at this point. Note that p53 link was only with severe autism. Maybe one day K will be used to treat severe autism- who knows
p53 and autism- severe disease correlated with loss of p53 normal function in patients and their fathers also. New article journal of pediatrics. Another maybe potential role for K, who knows
Do you suffer from K p2 PR fatigue? Re today's PR- please can we just start a phase 2 for K? pretty please? And not keep sending out pr's about it getting ready to start? Or getting ready to finish the filing, so it can be reviewed? Now we are stuck with final phase 2 submission is complete PR and then a FDA approves final p2 K ovarian trial PR, not to mention the eventual p2 K trial actual start, whenever that is?
Yes I am beginning to suffer from K p2 PR fatigue.
However to combat that fatigue, what about the fun of trying to guess what country the BUP trial will be in? There are all those new countries now that Yugoslavia broke up. Maybe the trial will be in Macedonia(landlocked Balkan nation)? There have to be places with high prevalence of ulcerative colitis, since inflammatory bowel diseases have some genetic basis. Is there a center of ulcerative proctitis abroad? I had not even thought to google it.
Or maybe it is even more fun trying to guess why the location of the trial country should be kept secret for competitive reasons? To keep out the steroid enema competition?
Life has its mysteries
A few thoughts:
The company says 1/3 to 1/2 of pts with UP develop UC. I do not know how many pts with limited distal disease- UP-develop cancer but significantly increased risk of colon CA is one of the potential problems for those with ulcerative colitis. We can agree that colon CA is a potentially deadly problem. Yes UP may be limited and annoying, but if a large percentage develop UC and UC dramatically increases colon CA risk it is important to recognize this as a potential bigger issue. You will come across lots of UC patients whose entire colons have been removed to minimize this risk.
The local ethics committee says go ahead? Waiting for national minister of health? Sounds sort of soviet. Why go overseas unless it is to save money? Are there more pts not being treated elsewhere, easier to recruit?
No mention of B-OM today. Was hopeful that since Leo said no proceeding with B-UP without info from B-OM that we might get some more morsels of info , but NO
I am planning on replying to this in March
On the other hand, I sort of like the idea that as CEO you can announce a lot of stuff that you did not really intend to do- sort of like when you tell your spouse that you plan to fix or clean up this or that, maybe now , or later, if you have time, if it works out. Vague wannado plans that could change, if the wind changes.
So our CEO could say that he plans to start a phase 2 trial for pancreatic cancer with Mayo Clinic in April, and that he plans to start the AML trial in June in Italy, but then later if those things did not happen, he could just say that it did not work out.
That's what we expect from the CEO? And people want to defend that? Vociferously?
If the CEO tells shareholders and the world in writing that he plans to start a trial for B-UP in March it means something. It suggests that B-OM is without side effects at worst, and at best, that it might be working, because Leo has prev said that B-Up and B for HS and B for conjunctivitis would not start until B-OM moved forward (exact words and meaning not certain).
It means something to us shareholders, rather than nothing, despite what many on the board say. Why pretend the CEO says a lot of stuff that he does not really believe? Leo put it in print, knowing that we care, and yet, that's just fine, doesn't matter, forget about it.
I think that if he changes his plans he should say so in an announcement because his prev words were optimistic, encouraging, and it means something rather than nothing, as some would have you believe.
Leo said march for B-UP announcement and we are rapidly approaching the...end of march.
One can only hope
And if you click on the link you provide and then look through full prescribing info you com to the PSOR-1 and PSOR-2 study data showing a 30% response at week 16 in each trial and 6% placebo response
It is amazing to think that ctix hopes to show a response in 7 weeks! If it works
thought one Otzela trial I saw was 30% response with 6% placebo, and the arthritis trial had 40% will check
but hiking this weekend may have to wait
Agreed that her response is the equivalent of telling someone that the glasses they are looking for are on thieir forehead- well observed
Fair critique, thanks
Usu the patient does not have to pay for the costs of the biologic(as you know, The costs are societal), but how much co-pay there is now with various plans I haven/t a clue. Can people here comment on co- pays? I think there is some famous gap with Medicare where people have to pay for some drugs- but do not know details, but I will try to look up, or ask around.
I did not see that Otzela was so tough with side effects but will recheck. Big deal with Otzela of course is that it also helps with psoriaitc arthritis too-
For K, I have been broken record esque to be sure about the dosing stuff for months now .
I wish to commend you for the the mot juste phrase "broken record esque"
It is a tendency, certainly, and yet the greater resources of the board- in this case Karen in a strong solo effort-have won out
Thank you Karen. Someone smart enough to carefully read through the endpoints has cleared up the P endpoints mystery, just as we hope P clears up psoriasis plaques!
Nice work
if they are using what most others use then that is fine by me.
leo's comments seemed to suggest something else
It would be nice to work the occasional imaginary shift, but work is my chief pleasure in life, as i Imagine it is for many of you.
Thanks for the suggestion- maybe I will write to Dr Menon.
Look- I have written in the past to Leo and have received answers, as many of us prob have, and then I find that I am dismayed to think that he would take the time to bother to reply, and I wish he would spend every minute on another task.
It had never occurred to me that Dr Menon would write back.
My original question was if people on the board knew something more about psoriasis trials, and why CTIX might choose to deviate from the standard choice of reduction of lesions on the entire body as opposed to what they chose. I genuinely believe someone here might know better- biodoc, or whoever.
Might try menon but somewhat embarrssed to ask someone able to invent Kevetrin to respond to an email.
Gee thanks for the reminder that I can sell at any time, as opposed to holding for K and B, which is why most of us are here to begin with.
But thanks again for letting me know that if I want to question anything, rather than ask questions to the board, I can just be quiet, and sell.
I go to the brokerage site, and at the prompt where it says trade I click "sell" not buy? Is that how it works? You can learn so much from the board.
Instead of reading about the trial, we would do much better to read more about why in the world CTIX would conduct a psoriasis trial that has such different outcome measures than all the other trials. I mean seriously, Leo, what is up with that?
Just have similar endpoints to everybody else and then we can get some sense of whether there is hope for P. But this bogus focus- my view only-is just plain weird. OK so one lesion gets better more frequently for the 25 patients in the 100mg BID group. What about all of their other lesions? Behind their ears and on their knees and elbows and all of the other places that psoriasis patients have their plaques. Just an excuse to move on to next trial? If yes, then why not give some REAL data for comparison with other drugs that are out there, and there are a lot of them. What am I missing here, it seems bogus, and crazy.
Does anyone on the board know a lot about psoriasis trials? Why would CTIX pick different endpoints than all the other drugs? How to evaluate it versus Otzela and all the monoclonal antibodies? They all pick a global response
I really appreciate your provocative and reasoned response. I had no idea they were pursuing such an odd goal- looking at specific lesions as opposed to a global assessment.
They show mice with striking global responses. what evr could be the logic of such a narrow focus? I cannot grasp it at all, and I failed to appreciate it despite reading about the trial earlier today- I did not read closely enough at all- thanks to Leo, and to your note, about the aims of the the trial. Pretty strange I think.
All of their competition( esp the monoclonals)report on the basis of overall improvement such as the PASI 75 measure Leo referred to in a recent PR, referencing Otzela and its success- albeit limited success, about a 30% response rate for moderate plaque psoriasis
I will re-read the paid puff piece and connect the dots if possible. The trial seems more mysterious to me. So few patients, for a short period of time, looking at single lesions? Yeesh.
If successful looking toward much bigger trial with wider response end points of course, with this trial as proof of concept only.
Possibly pivotal moment for CTIX if success as it will provide a chance to partner and to fund other trials(K).
Hard to fathom. We shall see.
So the "interview" and report are by somebody connected to Streetwise, which did the other recent piece, so it is no doubt a paid piece
all the stuff about looking at one single lesion in the 100 psoriasis patients- what the heck ?