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There was no bad news, really.
When the company reported on January 15
Hi Nateej,
I am still interested in this stock, and long, but with much less confidence than I did at the beginning. In fact, my posting here is indicative of being long. I do not short (I don't know that one can short BB stocks any way, unless you are a market maker). If I still did not have an interest in seeing how things develop I would not visit this board. But I am significantly more into other biotechs. I am holding CTIX with a not-so-tight grip.
In my eyes, the products are the positive side of the company, the management the negative. That is a tough mix. I only state these because you enquired. Part of this board is devoted to propaganda in favor of Leo and Dr. Menon, perhaps this was more so in the past than is now.
The PR's are intended for such folks as frequent this board, to keep our enthusiasm up. Today's is actually a negative news, with an undiscerning spin by the CEO. For instance, some sincere followers of the company on this board have been counting the weeks and months of the 7th cohort, which unfortunately had not begun until now. It could have been just paperwork delay. Changes in protocol may have to go through the various compliance monitoring offices. I don't know. But I wonder how much enthusiasm Shapiro and company have for this trial if it takes two months to start a new cohort simply because of a change in dosing protocol. Leo indirectly blames the hospitals for the delay and it makes me wonder about the impression Kevetrin is making on those conducting the trial.
The really funny part of the PR is the milestone comment. In reality you do not want to hit a MTD. You can begin phase 2 without any MTD, as long as the dose is below that. For those spending money on a Phase 2 or 3, you want to be convinced of the possibility of efficacy, that is all. There are several clinical trials going on in other companies that I follow where dose limiting toxicity (DLT) was not encountered in the trial, but the dose had gone high enough for them to have confidence to proceed. So either Leo does not recognize that or he takes the readers for fools.
All the best.
Infallible logic as always! Now that Kevetrin and Brilacidin are already approved, marketed, and used, and you have made millions from this investment, who cares what Dr. Menon did at Lilly!
Thanks for that excellent re-orientation of perspective.
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What I found positive about today's PR.
As many here might recognize, the dosage is a major issue about Kevetrin that awaits resolution as the trial proceeds.
I was a little concerned about the request to the FDA regarding the 6 hour limit for administering K, wondering if it meant some toxicity was being detected and if the request meant prolonging the administration. It seems that the intent was just the opposite. The existing protocol might prolong the administration and the change allows faster administration of K. This gives at least some (favorable) indication of how the trial is proceeding and detection of adverse events.
Today's price action might simply be what is often seen before catalytic events. Those who bought in anticipation of price rising leading up to the event cash in for profit without awaiting the outcome. In my recent experience this happened with CYTR. There was a huge sell off the afternoon before a major result announcement and the price popped to double the next day. This doubling or even an increase may not be in the cards for CTIX today, but the strategy might explain today's action.
Regards to all.
Hello all, I am new on this board, although I have been active elsewhere on ihub.
Wanted to respond to the following put to me on another board (and after I responded saying it was off topic there, I would respond here, it disappeared):
Citrati, did you see what happened this AM.?
Thanks Akamaii.
I just posted something that may have already replied to what you reasonably point out.
ETL, no disrespect felt.
But I am for real and all the money I have risked and continue to risk for having taken the various officially disseminated statements of Mssrs. Ehrlich and Menon at their face value is also very very real.
I post here not in the interest of pumping the stock in the hopes it will go up, but as a means of communicating with fellow investors to hold the management accountable. When I conclude that this is too bad a risk, then you won't find me here any more. For now, besides my own holding, I feel responsible for having led some into this stock.
Some of you here are so funny with the name calling and all. I point out facts based on the company's past and present official news releases and you want me to explain what their motives are. It should be enough to assess actual statements and facts to judge the veracity of claims. As for motives, one can come up with any number of speculations. This board is famous for inventing motives for anyone who expresses the slightest doubt about the infinite prospects of CTIX as a stock.
As for the Prurisol plan just announced, it does nothing to change my view about this company from what I had yesterday. I had pretty much completely discounted Prurisol potential from my valuation. The new twist is simply another turn of delay to one that has been going for a year. We have been conditioned for this in Pavlovian fashion.
Obviously, I have taken some poetic license with how the company consulted industry experts (but the caricature is probably closer to truth).
Now if we could have some honest response:
How many on this board were expecting a Phase 1 for Prurisol instead of a "Phase 2/3 under a 505(b)(2) designation"?
Here is the last PR on this. Read carefully:
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Speaking for the other side now, while sympathizing with and sharing the frustrations ...
there are some silver linings. Kevetrin is progressing through Phase 1, cohort after cohort and as Gov keeps reminding us, no DLT yet!
Brilacidin may be part of a heap whose quality assessment is not available to us, but B itself went through a Phase 2 and there are data on it.
On Prurisol, an October 2 PR said that the CMC from Reddy's was expected by the end of the month. That seems to have happened pretty close to that goal(the news was released this week). We don't know when the trial will commence even after the 30 days following the filing of the IND or when the filing will be done. However, they are sitting on a bunch of Prurisol tablets all bought and paid for. Something has to be done with them before they go bad.
I agree. Found it to be quite positive. It is also positive that some of the scientific personnel of Polymedix have been recruited (to whatever extent) by CTIX. Also the numbers mentioned there for oral mucositis treatment cost ($10k/patient/yr) agreed with what some have posted here, if I recall right.
Thank you 58. Here is the link for those interested.
This kind of gift just keeps on giving. I don't discount it.
I am a sucker. I could not wait to look for the Monday morning update. The update was there. But it made me think about some pegs of wisdom out of WCFields. May be the following will make you chuckle and forget about CTIX for another week.
Never give a sucker an even break.
It's morally wrong to allow a sucker to keep his money.
There comes a time in the affairs of man when he must take the bull by the tail and face the situation.
If you can't dazzle them with brilliance, baffle them with bull.
If at first you don't succeed, try, try again. Then quit. There's no point in being a damn fool about it.
May be this will make some of us happy:
If there's a will, prosperity can't be far behind.
Thanks gov. I am being conservative by not reading efficacy into the stabilization, recalling the back and forth regarding that on this forum. Just waiting until there is no question on the matter.
To be fair, we have had only a preliminary report on the effect of K on patients. The doses there were too low to expect any efficacy, and efficacy was/is not the focal point of the Phase 1 study, but safety.
The dose currently being employed in the Kevetrin trial is more than double the highest dose in what was reported in early 2013 (if I recall the numbers right) and it looks like K has further to go.
Once the maximum tolerated dose is established, efficacy trials (whether K by itself or in combo) would be undertaken. We really don't have enough data now to have any certainty on the outcomes. It is simply that the methodical nature of the trial and the concern for safety and the nature of the disease being treated makes this procedure to be long drawn out and demands a lot of patience from investors.
While it could still turn out that K disappoints, the fact that CTIX is not a one-trick pony is extremely significant. IMO, any one of three successful products will more than support the current market valuation of CTIX.
Furthermore, the other company had a market cap of a billion before it dropped to half a billion. CTIX is under 200k. What is more, in the case of the other company the market may be wrong. The results were actually positive in that half the patients in the trial responded at below maximum doses (and I bought at the current price).
The lesson to be taken from the example you point is that the market might react irrationally to information that is released and an investor needs to have stomach for that.
Not wanting to discuss other stocks here, I had actually looked that one up; the drop was because in the limited early trial only half the patients showed a response. It was not because of not meeting DLT. Not encountering DLT is, obviously, positive, since it gives you higher dose ranges to try.
So as far as Kevetrin is concerned we should be happy to hear no DLT encountered until the 20th cohort or ever.
Nateej, I think your question is perceptive.
The explanation was not really given by Leo at the R&R show. He simply said something about CTIX now being a stronger company. Those writing on this board provided the explanation that P now will not be put up for partnership and Brilacidin will fill that role. It is possible that this explanation was then brought up to Leo in the subsequent interview and he went along with it (I did not save that SA report and it is now inaccessible). In any case, the presentation at next week's trade (or whatever) show validates the interpretation that partnership is being sought for B.
There have been enough public statements about the production of the Prurisol tablets so that we can conclude that the company has a supply. Also one of the press releases in the last month said that the Polymedix asset acquisition and the Prurisol (quantity/lot manufactured at this point) was all paid for. In addition Dr. Reddy's Labs, which manufactured the drug, is writing part of the report needed to file the FDA application for the Phase 2/3.
Even so, it is clear from the recent press releases that Brilacidin Phase 2b trials are going to be the first priority. The explanation by participants on this board as to why that is so is that the company wants to keep P to itself and will trade rights on B to get cash to develop others (K and P now) without giving away profits from them.
not being unfair to the management
I don't want to spend your time and mine, or space here, defending my previous comments. I had already stated that I expected some of you to strongly disagree. However, I will briefly respond to characterization that something I wrote was a "cheap shot," as well as about what was meant by "betrayal of trust" and "hype" (=hyperbole).
I was not taking any shots at the management, merely describing what I felt were underlying reasons for investor apathy. So, the statement, "people here are 'far more confident' with the released data than our management," was negative not toward the management, but toward "people here." I read Leo's comments both at the R&R meeting and in the subsequent KarinCA interview as not wanting to to boldly assert that p21 had clearly been detected. It sounded as if whatever was detected at low doses was still within the range of potential experimental error, which means it needed to be verified to be more sure. So I meant no criticism there toward CTIX.
As for betrayal of trust, it does not have to mean "cloak and dagger" but simply that when he kept saying the Prurisol PoC is about to happen many believed him and bought and then he let them down. That is all. The cloak and dagger are added by the others.
As for whether there is hype in the press releases rather than understatement, all I can say is, "ah, come on!"
Read the following recent examples:
Sept. 24:
Regarding your post I am confident of two things: 1. I agree with most of it. 2. What I am not sure about I am willing to wait out and see.
Thanks, LR, for clarifying that.
Hi ET,
You would be most welcome to forward it to Leo.
Shalom.
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