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I recall no statements about great results. He said that B blood levels are low and that participants in the trial are enthusiastic. Nothing more exact, I believe. Nothing to form any basis for legal complaint
Instead he said he would release info last week
If the results are not good it will trigger disappointment
and it will trigger a big fall in share price
but no trigger for a lawsuit
or what did I miss?
your question: what other reason could there be other than CRO problem? For the delay?
Possible answer: results are not that good and the company has to find a way to present/spin the data.
which first? What if results allow no movement forward?
Just 2 steps back??
Let's see- they had all weekend to get the cohort 2 UP data together, if there was just a delay.
Now it really is starting to look odd, if still no release.
Price cut by half if bad data?
Failure of B-OM shares leads to a dime?
C'mon CTIX ! Time to move UP not DOWN
Thanks for the reassurance.
I would hate to think that the data from a brand new drug might be equivocal, and that a bit of misdirection might be employed as a defense, to gain time. Until you report less than stellar results....
Bologna?
SpragueHawley?
How about more about lyophilization? And p21?
look: all's well that ends well and I expect the same- good news this coming week.
It is just a bit curious though
Thanks for making my point: as I said, most people just do not care about leo saying he will address one thing and then talking about lots of other things, some pretty far off the map
Nary a concern expressed about PR focused on everything but what we were told it would say?
No worries that it means that cohort 2 was not a smashing success like cohort 1 for B-UP?
Why so much chatter, all over the map, when simple good news about the sigmoidoscopy data would suffice?
Nervous, even more so, but hopeful
Kevetrin GUM may be the way to go. Given that short half life now applicable to oral dosing as well. Or a patch. Applicable model may be nicotine delivery.
Only partly kidding here, who knows how they solve the problem
Oh yeah- one other little detail- - does it save lives? Or months or years of lives?
Just keep waiting....for a real trial
of course you are right(as if)
I mean Bologna- it is so exciting!
at least it was
back in 2013 and 2014
back when so much was supposed to be happening until it did not happen
oh well
sigh
And the Sprague Hawley dogs? And Bologna? Again, with Bologna?
Not even a smile?
C'mon dude this is just too funny! Way to go Leo!
Laugh out loud PR !!???!
I mean seriously, folks. There we were hanging on for PROMISED info about our illustrious anti inflammatory future, when instead we got
Sprague Hawley dogs?
New stuff about K, the cancer drug never shown to benefit patients, one big trial scrapped for a new safety trial- gosh, that is exciting, right?- and yet, here we go with more info about the new oral dosing.
Sigh.
And not just that- crank up the laughs, with more about Bologna. Just when you thought the PR could not get sillier, well, there you have it. Bologna, and all of their crucial clinical data. Now there is a laugh.
A word to the wise- do not hold your breath for the big glioblastoma trial from Bologna. Ha!
Perhaps you wanted info about the pipeline trials CTIX has been pushing so steadfastly:
Were you hoping for something about ulcerative colitis- wait till next week!! So there!!
Do you want more about B-OM? Not a word!!
And Prurisol? Not a word( and not a word for several recent PR's- all the rage and now not even worthy of a mention
Hey everybody- pour a glass of wine and re-read the PR - is this April 1? It succeeds in terms of humor- though not in any other way!
Don't you feel better going into the weekend???!!?
when Leo specifically says the results will be out this week- just a couple days ago- it makes you wonder
sure good news maybe better at start of week
that is not the point
the question is, why the delay when he was so clear?
sure, we do. But if results are not good, the share price is gonna suffer
I am the nervous type
no cohort 2 news? despite saying it would be out?
Strange.
Should we be worried?
cohort 2? Bueller?
given the current dreadful state of the ctix union i think poor cohort 2 results- unlikely, but certainly possible- would hurt share price, even though good results may not help right now
24 hours: B-UP results supposedly out this week, right? Guess what good news will do for share price? Prob nothing. But helps immensely for long term shareholders
of course you are on the right track, although who knows exactly how the cancer treatment world will look like in a generation. For sure chemo as it currently/recently has played out has a lot of disadvantages, to put it mildly
I would qualify as a quasi science person, only- sorry
the most important point that the abstract says- to me anyway- is that cancer is a very diverse disease and that many different cell types are expressed, and need to be addressed for treatment. What we call ovarian cancer, just to take that example, is really composed of many different cell types growing out of control. Kevetrin seems to help stop growth in different subtypes
Look: lots of people here are thrilled about the next trial and I am still very unhappy that we are stuck with another safety (for the most part)study
But in the long run what the article hints at is personalized medicine and viewing cancer at the genetic level and basing treatment very specifically- as opposed to right now, where ovarian cancer and pancreatic cancer etc- with many different cell subtypes and many different aberrant patterns of growth- are all painted with the same broad brush and all given chemo for group of diseases. In our lifetime this will all change, as it has in part already changed. So much more to come that it is exciting to witness
will K have a place in all this? We can only hope so
CTIX: your oncology then infectious disease then dermatology now anti-inflammatory entity
WHO and a dirty dozen bacteria!!
WHO has released a 3 tier list of bacteria that need new antibiotics
Brilacidin? Hello? Is that you up on the shelf? Way in the back of the cupboard? Still up there? Will you ever be heard from again, except as a second bankruptcy auction item?
And what about our gram negative drug, whose number I cannot recall because it never gets talked about anymore?
Sigh.
Oh yes, we are a dermatology company, despite the fact that our big derm drug Prurisol barely succeeded in making it past a phase 2a study, going forward only by the very narrowest of margins with very small numbers- count 'em on your fingers. That is a dermatology company? maybe if P2b is a clear success- what are the chances of that? 50-50?
Tier 1 has Acinetobacter baumanii and Ps Aeruginosa and ESBL Enterobacter. We are aware of the problems the gm - drug had with Pseudomonas, but between Brilacidn and the proposed gm- candidate,CTIX could actually be a real infectious disease company.
but we have to be a dermatology company first? Just wait till Prurisol fails, and there will be a whole new spin. Or- are we seeing it already? Recently all the focus is on B anti inflammatory effects, and Leo does not seem to be talking up Prurisol trial data-hmmm
Let's see, add 'em up :oncology then ID then derm then anti-inflammatory. Whither CTIX?
nice to see him talk- but who knows what it means
there was no special focus on breast CA for K during prev trial
and nothing ever mentioned- as opposed to renal pancreatic AML etc
and what about asteroids? Do you worry about them?
I could not agree with you more. Just thinking about asteroids and their impact on share price- not to mention the planet.....
actually it was a real question about a worst case scenario
as the share price keeps on truckin
down
if B-OM and P results not good, exactly what do you suppose this company will be worth?
It ain't much
oh I get it- they can generate one report, serum levels- much faster than they can generate the other - objective video and subjective patient data? All measures would have to wait till the end of the six week time frame, certainly
nonsense- he will report the very least bit of positie info as it becomes available
As he has already done
whadda we know about cohort 2?
patients are enthusistic
serum levels brilacidin are low( or at least he says they are)
we know this because ctix will tell us anything positive they can given dire staits
p2a inconclusive, yes that is what I would say.
but people were buying as we came to the results coming out(p2a)
Where is the buying now, as we approach results(B-OM, p2b) is what I am talking about?
Where, or where?
Current problems: as the stock approached the prurisol trial results release the share price went up. Now, as we approach B-OM results, and interim P results(when, actually? Conveniently left out of last PR. Makes you wonder...) the share price just keeps going down.
Even when you cannot imagine it will keep dropping, it keeps dropping- no one is worried, right? It's just bargain prices that we should be thankful for, right?
B-OM is a big deal for CTIX. Does someone know something we don't? Why the endless dumping of shares at ever lower prices?
for those with more financial knowledge: if share price goes to 0, and assets are then sold off, do shareholders get a share of the proceeds? Would we get a chance to benefit from sales of Brilacidin and Kevetrin?
my point exactly. Why can they tell us picky little data about Brilacidin levels and nothing about photos/ disease progression? This does not surprise you? Just a little bit?
Based on this I predict results will be less good than prior group.
I was very optimistic about this next round given the patient buzz reported by CTIX- people feel good and they want to be in a study where they have to get an enema every day for 6 weeks!!
Now that is an endorsement.
It may still play out that way but today's PR is peculiar
They can tell us the serum concentration of Brilacidin for this cohort but they cannot tell us the endoscopic data? Does that make any sense? So what aren't they willing to say?
re K trials: if this trial is really better than what they had planned, then why didn't they plan it all along?
They wanted a worse trial, and told us it was just about to begin, and good riddance?
Safety maybe established for K
Efficacy unknown
the soonest path to proof of significant increases in survival compared to established treatment is the best path
in 2014 they were writing about how they wanted to do more frequent dosing of K in the Bologna trial.
2014
They could have planned a trial like this before
Ok then: you would argue that this is better than the trial they had already been talking about with the FDA, and that we have been hearing about, and that they said would start last quarter, a real trial with survival endpoints? You may remember it- the ovarian cancer trial with a combo agent? Breathlessly we got details from CTIX- talks with FDA final plans put in the mail, every step along the way. remember?
This is better than that? This is the best they could do?
it does not represent any step back in any way?
Where is the CTIX PR trumpeting this giant leap forward for K???!?
Explaining why it is better than what they SAID would happen, a long time ago already now.
as I said : it is a bad thing that the PLANNED trial is dropped
it is good that they are going ahead with K
Is that hard to grasp?
Just try, ok
Can you argue otherwise: That this trial is BETTER than the one they have talked about for months?
Utter nonsense
could not have been done faster?
As if.
When they have known for years that K needed many x per week dosing? And that safety at such doses was not established?
They could have planned for this many moons ago
not to worry- if there is no efficacy demonstrated, you can always say it was primarily about safety
hey read initial protocol for K, at its birth
Sound familiar in terms of what was measured? That is because a lot of it is the very same stuff
They would love to demonstrate any efficacy in a phase 1
We are right back in the same spot
awaiting a real trial with real very big deal endpoints
(as long as it really is SAFE)
all of those same measures- or at least many- biomarkers etc - applied to the phase 1 before, way back at the start of Kevetrin, at its birth.
There is not enough time to follow patients for real benefit,
and most of all, the REAL endpoints, patient survival- gone!
Recognize this development for what it really it:
Big setback in the kevetrin time frame!
What is so hard for shareholders to admit: this is a big step back for CTIX, in the near term.
In the long run it may not matter.
But for now this is a real change, and not for the better
as prev said- initially looked at percentages supplied by company, and never really thought much about it. P never my focus, initially. As company put so much focus on the drug, and Bertolino says slide 11 led him to join the company, I thought about it bit more. The overwhelming sentiment here is that P is an easy winner in 2b. Any look at the actual numbers make it clear this is not at all the case.
The ability to predict kaboom is not supported, though I would prefer to believe otherwise
I am tired of averaging down
Look- I am very much interested in B OM results, adn I still believe in the company, and I am still buying shares
But also note folks- BIG STEP BACKWARD with respect to K going forward apace as we do another safety trial. It has been suggested here with posts how great it is- the news is a let down, plain and simple, for K
That of course is the short run, and who knows about 2020 - 25. But it hurts for now
Thanks again.
I really appreciate your willingness to do the math and to post.
Yes I got thrown off by the denominator, and then gave up
Still do not understand why they chose 28
At any rate: 7 responding in 200mg and 4 from placebo improved?
My general sense is that the numbers are small - as before.
Why did they miss so badly with initial choices of dosing? So it goes I suppose- if 300 and 400 mg show any benefit.