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maybe, but what is a positive study if there are no controls?
Fine then
I am wrong you and others say
So how much then will it be worth? Let's say that Leo says 10 of 16 patients, in whatever country they happen to inhabit, have improvement of disease based on sigmoidoscopy.
How much more will CTIX be worth?
I say little or no increase in share price or value to a partner.
What do you think?
Recent 2A Prurisol showed some positive results and the share price went.....down.
the original discussion of all this came out of a sox post regarding 2016 catalysts.
I do not see B-UP as a 2016 catalyst even if it is successful.
So we disagree
I see value in B-UP when and if there is something with a control group
point? That there will be a near term collaboration that will be enhanced by putting a shine on Brilacidin anti inflamm apps?
Have I now correctly restated your point, since you decline to reiterate?
We disagree
I think B-UP POC study has very long term value, not short term, as I explained at length in my post about generalized UC and IBD
sure of course
they wanna show Prurisol works to help fund other trials and they wanna show B can work in many wonderful ways, and if it does, it will be worth a fortune
Yes- that is why we are all here
In addition to Kevetrin
Not at all.
I am well aware that ulcerative colitis is a big deal. I see patients with UC all the time and I have family with UC.
This is a very very early study without any controls and there would have to be spectacular results to see any share price movement.
Real action will occur much later when and if there is a controlled trial.
What expanded indications do you mean? For HS and conjunctivitis and for external otitis? These indications will go forward if B-OM is successful , or so we have been informed prior.
Expansion to ulcerative colitis generally, and not just distal disease(proctitis)? Leo has referred to other
IBD- Crohn's disease- as you know, an entire gut disease, not just rectal at all, as possible candidates for Brilacidin treatment. Who knows. But they are testing an enema, and nothing systemic. If you mean Brilacidin as an injection for generalized disease, maybe one day that could come true. But then you'd be giving an antibacterial agent also, when trying to focus on the GI tract. Therefore the need to develop a GI only form of Brilacidin. There is no oral Brilacidin yet, but this is still very different from an agent that would impact only the GI targets. Will they / are they working on it? Probably lots of attention if this B-UP trial gets anywhere.
Of course there are implications for UC generally and IBD (inflammatory bowel disease) generally. But ask Dr Farraye how easily the enemas will translate to treatment for not just distal UC and for Crohn's and I am sure he would tell you that new formulations would be needed and that it is a long road.
So I stand by what I said- NOT a big price mover even if this first study looks good.
intriguing? Exciting? You bet. One of the reasons I have not sold a share and I keep buying.
But I do not see it as a 2016 potential catalyst. If there were a control group I would feel differently, but as they said it is very preliminary and proof of concept.
Catalysts? I suppose "potential catalysts" takes the pressure off, since potential leaves a lot of wiggle room
BUP interim very unlikely to move price - not controlled trial.So if 15 of 16 clear up a great deal, might help a smidge
Start of P 2b expected no boost
Start of K ovarian p2 - overdue and expected no boost
K top line data- you are kidding, right? NO boost, data known. This is like expecting a boost from an academic journal article, another poster favorite boost(not)
We are let with B-OM. Any chance of interim update 2016? Who knows. I would bet 2017.
In other words, there is little going on in the near term in terms of actual catalysts. Check back in 6-12 months.
I will expect less trumpeting when I see it
right now same mode CEO PR with B-Up best recent example
And cheap shares will be available until we hear B-OM results, and that is a LONG time from now(barring early partnership)
no way leo loves to trumpet anything positive(see file listed under disappearing spleen)
but we do agree on- lots of time to get cheap shares
cheap shares have been available here ad nauseum
It has been one very extended buying opportunity!!! How great!!!
setting a precedent:
if ceo announces first patient B-UP initial results in such hyped fashion, then it begs the question why no more info? Because it is not good? Because if it is good he cannot wait even a minute to tell us all about it.
And would you also say yes to the question of wouldn't it be nice to know if there were ANY single agent benefit at realistic intervals? For any cancer?
glad we can agree then, about the short term.
Odd though that Leo must see it differently than you- right? If he goes out on a limb to announce how one patient is doing after a coupla weeks with B-UP, just to name one example. Instead of saying, biotech takes time, we are working on it? Which is to say, eliminate most of his PR's?
Fine. So, as a starting point, let's talk 2 years hence Where then will ctix be in august 2018?
IF prurisol does ok we will have some sort of a deal in place .
IF p and B-OM have good results then ctix will be on the move, somewhat
If the very small numbers of patients getting better with P do not pan out in 2b, and if B-OM not a success, the stock will be near sinking, holding on for a Kp2 trial which will still be ongoing. Without any money for Bp3.
We will still be talking about the potential of K since it will be in a trial- results maybe ASCO 2019.
Sad for all us shareholders that they could never get around to treating 4-5 ovarian and renal and pancreatic ca pts with actual reasonable dosing as a single agent, just to see if K could have an impact. At real intervals, not those thus far tested. Or is that a stupid argument since combo treatment, where they are now headed, is the name of the game?
CTIX- not to worry. One can vanish from the grid as I just did for 2 entire weeks and return to to find nothing new of interest. The same could be said for a 2 month gap I bet, July August.
And maybe even much longer.
No more info about B-UP? Why not? Hushed tones of excitement with patient #1, but....nary another word.
A rehash of stuff about Kp2- we are going to start the trial- eventually? That was worth a PR? Yeesh
Expedited? really?All we have heard is how slowly the trial is going due to lack of enrollment. Will expedited simply result in meeting goals? if truly expedited how about some data, and a timeline? That would be nice.
Of course they do not know how fast they can get it done since they did not anticipate the slow enrollment either. So who knows.
At least they are trying. Wouldn't it be nice to have some initial data?
Does the company know something that we do not? Some signs of benefit that lead them to add Sonis? And now to try to pick up the pace? It certainly seems that way.
Let's say B-OM good results and P good results. Partnership by this time next year ?
And Bp3 and Kp2 to start a year after we all initially hoped?
One patient in one unnamed country has improved distal colitis subjectively and presumably objectively.
Shareholders for ctix are so desperate for any news that we will gladly welcome this PR.
It is better than the alternative- no improvement. Placebo? Disease variability? Who knows.
It is still some good news-
Of course agree with you that B-OM and B-UP have a lot of potential, to say the least. Just one of the reasons I have only bought and never sold
As I have prev written I do not think they added Sonis and Farraye for no reason
and now a dermatologist is on the team too?
side note- in your interview I was v interested to see that Bertolino said abacavir hypersensitivity reaction went to ZERO when allele testing was done first.
From what I was reading when looking into Ziagen, they(drug adverse reaction lists) still listed hypersensitivity a s a rare possibility AFTER the genetic screen
I imagine Bertolino knows what he is talking about,and that would be good
point taken
and we are all happy that at least something is moving forward
oddly enough that very speculative trial may be best big bet for ctix
wish they'd at least had a few controls-
Proof of concept Phase 2 Not a real phase 2
NO CONTROL group
prelim v prelim only.....
Hey it's time for a new pipeline!! To replace the one above us here on the Ihub ctix banner!!
We can put one heading:
Actual ongoing/ v soon to be ongoing trials
B-OM
P 2B
Next is maybe trials, we don't know when
K p2 ovarian
Next is Temporarily shelved
Brilacidin
Kevetrin- other
Next is purely speculative
B-UP
1807 gm negative drug
B-HS
I see what you mean. After all, who would ever have guessed that they might try to partner P? What a novel idea!?
I mean duh, they have only been saying this for like, forever.
While they have NOT been saying that B p3 was just gonna have to wait to see if anything else might pan out.
Let's see- we are focusing on the new news from Bertolino, and failing to pay attention to what we have known all along- that they will partner P at the earliest opportunity.
Yeah- that is the part that got my attention. You know the part about how our only drug ready to start a phase 3 trial, a revolutionary antibiotic, is put on hold while we focus on more speculative products.
Brilacidin will now tread water for a while-indefinitely-while we fund some other stuff that might pan out.(Yes I get it that P and B-OM may be worth an awful lot, someday. They may also be worth nothing-)
What then does Bertolino and the company know about Brilacidin that we do not? Is it only that there is no money for the trial? Or is there anything else?
C'mon Brilacidin, keep loose on the bench. You might get in the game, eventually.
Maybe.
For now keep your eyes on the unproven players out there, like B-OM. And P. And B-UP (And a dermatologist does not even manage to throw in even a word about B-HS? Amazing)
The B- OM trial, by his own and Leo's admission, is having trouble getting patients enrolled, and how soon we get any results is anybody's guess. I agree with you about the potential of a good mucositis drug- who would disagree?
The B-UP thing is such a first baby step that it will be hard to say how much it would help even if it looks promising. Very preliminary.
I think that your interviews are excellent, and represent a lot of hard work, and I, and every one else on the board, is in your debt.
I just wish that Bertolino had found another way to say the same things. He is bound to do better his next time out as a company representative- could it have been worse?
Bertolino's first move is to tank the share price? Talk about an error. You announce there is no money for B and the big trial is on hold. Your most proven product must - sit and wait. Be put on hold
While the company puts its faith in riskier pipeline products(P) to raise money?
In the end that may be the only way out but what a thing to say. Can the company even survive? What if P does not pan out? The numbers of patients in the trial were small. If 2B does not look very good then B and K ...what exactly? Who knows.
Cannot believe he said what he said the way he said it. The best way for Bertolino to approach the topic of where the company is going? We all know where the share price is going, at least. It is going way way down. thanks a lot
This is very predictably ugly
About a year ago ctix traded up to 3x current share price approx
now suit dismissed and P shows promise, and share price a buck and change?
Darkest before dawn? Things remain bleak for now, share price wise, promising pipeline wise
Let's say B-OM and B-Up fail, which they may well
Let's say K never makes it, also very possible.
Still worth much more in the long run with B only and P, if they can settle on a dose for P and prove that it works.
The clock keeps ticking
Still no word on B p3 and K p2
Hard to watch
I cannot say I know even one MD PhD MBA. If you end up in business is it because you could not really do your other jobs? Or because you can do it all so easily? Seems odd to me
What K news? None pnding that I know of
Yes announcement of K p 2 but that is expected.....eventually.......
It is unsettling. Novel technology has a lot of risks, and clearly in this case, some disastrous results. At the same time early trials have suggested unusual benefits too.
It is not Macedonia. I refer of course to the B-UP trial. Once again, I am willing to share news with the board that you cannot get from CTIX itself. They still won't tell us where the trial is being held.
So I will tell you where it is not being held, and will keep the B-UP in the news, and in your hearts, where it deserves traction.
Why no notice of the country where it is ongoing? Makes one wonder if it even exists.
Should I care ? Should we care?
2B, or not 2B- I think we will wait for a partner until after 2B.
Of course they have to find optimal dosing. But it will be on our dime, not anybody else's, is what I think.
Doesn't mean that I am right. It's an opinion
C'mon autumn. Nothing at all will help ctix this summer, only some shot if benefit of B for UP this fall news- the trial was 6 weeks I think.
Sure there could be a partner anytime for other drugs but we were just told no P partner anytime soon, in essence.
Can the stock hold above a dollar?
Extended buying opportunity- most likely till B--OM results or P2B results- which will come first? Hold your breath till June 2017, at least
The real message: no partnership offers for P good enough so far, so next phase of trial to be undertaken by us, ctix alone, to see if better results are achievable.
B-UP update. Yes ladies and gentlemen I am here to report, on behalf, or should I say in lieu of, any actual CTIX info, that the ongoing ulcerative colitis study is NOT being conducted in Madagascar.
Would we care where? Why not reveal it?
What is the big secret?
BP3? KP1B?
c'mon CTIX let's get a move on already
Oh- sorry- I forgot
Next news will be meeting with FDA about B-HS. The on again off again HS saga continues......
I am going to speculate here and say that the Ulcerative Proctitis trial is not being held in Mongolia.
Not such helpful info, you say?
It is more than CTIX is saying for now, which is NOTHING.
What is the big secret?
tried reading through avelumab data ovarian ca and response rates are not sensational, but it was a quick read
what was sensational was the extent of the avelumab trials- many many trials with different cancers, with several other drugs
would be nice to see such a lot of action for Kevetrin
and yet we are reduced to
a single
1B
maybe in 3 years it will be a lot different
PR idea- OK here we are right at the start of summer and the news cycle - well. we are waiting for B3 and for K2 to get off the ground(sigh)
Perhaps ctix can announce each day a country where the B-UP trial is not being held. This would at least keep us interested in the preliminary study, at least keep us on the edge of our seats. For I feel my interest wane , already.
Or, they could announce a continent a day where it will not be held. And then when we know the continent they could start spelling out non-participating countries.
But does he have enough education???!?
Perhaps a few more degrees?
There are still a few at least out there
would be shocked that big pharma would be behind such a preliminary phase
doubt it has anything to do with trial site
why won't they announce it?
bogus-
Sorry just got back to this today
I agree with your point about antigen targeting and tumors having/developing resistance, whether they are liquid or solid tumors, which is of course why so much current therapy is combo treatment.
And I think you are bound to be right that future treatment will continue to be combination therapy.
What makes me nervous as a CTIX shareholder is the force and the size of the CAR-T wave.
We know that in preclinical models that Kevetrin may be a useful combo drug with current chemo drugs, for example Docetaxel and K in ovarian CA, and a variety of drugs tested at Mayo with K for pancreatic CA, and with sunitinb and K for renal CA. I feel very good about the chances of K fitting into these regimens, if the trials will just get underway already. In this world of current chemo agents, I bet K will find a role. How big, who knows. But there is information already at least on multiple fronts.
If anyone knows anything about Kevetrin and CAR-T I have not seen it.
I hope K will be used with lots of anti cancer approaches, but it remains to be seen.
If K were now where aprea 246 is, I would be much happier.
How much of you hopes for CTIX as a company are tied up with Kevetrin? Unsure of my own answer, would need to ponder. Recently I would have said no hope for Prurisol, and maybe 30/70 or 40/60 Brilacidin/ Kevetrin hopes for the future of the stock value. Now of course Prurisol would appear to have some real value.
I just wish that they had been able to dose patients with 3x week Kevetrin already, even 10 or 12 of them, just to see if the little bitty hints of efficacy have any merit. I suppose though, that given the need for combo therapy generally, it is better to know how well K plays with others
Not suggesting that CTIX will have to give up on K- who knows how it will all turn out. I certainly do not.
Simply noting that solid tumors- including one that CTIX has selected for K-may now be legit targets for CAR-T. Yes such therapy may never come to pass. But as far as cancer investing 101 goes, that is where a lot of money is, not just start ups but in big pharma too.
Look- I am just trying to keep an eye on the competition, and CTIX and K do not such a big lead on anybody. We all have the chance to watch and see where it all goes- who will be closer in 5 years for clinical use in pancreatic cancer? K or CAR-T?
For ovarian ca the obv answer is K, less so for other tumor types
The times they are a changin'
Gee thanks so much for your caveat. Of course I am aware of the problems so far
Hey dude, guess what- where do you think big pharma is betting? They are working frenetically to get out in front with CAR-T, understanding the risks and the benefits.
Do you think the folks in charge at Novartis etc know anything about cancer investing 101, as you call it?
The precise reason that I posted this is to point out that now there is some success with a solid tumor model>? This is actual important news for the board, since everyone here says they purport to "know what they own".
Oh yeah- this is much bigger news than our new hire- sorry
The times they are a changin'