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Dont forget the unnamed world renowned clinic in Minnesota (Mayo), the large BP validating the use of Brilacidin for topical antibacterial applications (which CTIX cannot name because of non-disclosure agreements), and the University of Bologna in Italy, who would have been running a K phase 2 trial on their own dime if not for government funding issues.
Thanks for responding to that false statement to clear it up. CTIX was able to expedite the phase 1 SAFETY trial with P by utilizing the existing and known safety profile of Abacavir with the FDA. To claim there are safety concerns is an outright lie.
@runninggirl: Unfortunately, I didnt quite catch what you were saying. Do you care to try again? ;)
I dont think that pinning the blame on the FDA has anything to do with the decision. There is a process for everything and each step has a certain timetable attached to it. This is basic critical path scheduling. Determine what tasks ultimately affect the final outcome and then run the non-critical events in parallel or delay until it is pertinent to focus on them. Dr. B likely understands all this very well and decided to put B P3 on hold for a couple months to re-set that process timeline. That way CTIX can focus on the other ongoing items which will setup the additional funding they'll need for B P3. So as of the 10k CTIX is telling us that they feel the SPA can now be picked back up because the timeline of getting the FDA SPA guidance approved will run in parallel with the progress on the other fronts.
Correct. That is how I interpret it.
The information you posted answers the questions you are asking. In April CTIX announced that the FDA requested changes to initial submission and they were going to schedule a meeting to discuss them. We don't know if that next meeting occurred, but in July CTIX planned to delay the response to the initial request for changes. (My hunch is the meeting was determined to be unnecessary because Dr. B has enough experience and knowledge to understand what the FDA is after and therefore decided it was not needed. Just a guess though.) Now the September 10k states that the delayed response is being prepared so that it can be submitted, essentially a 2+ month delay.
I venture a guess that CTIX knows that it is likely that the next submission will not necessarily lead to a buyoff by the FDA and another round of questions and answers may be needed. So likely they delayed response was purposely just to push back a few months knowing that the remainder of the process will take through the end of the year. CTIX is not looking to start the B trial until first half 2017, so they are not in a rush. It is clear to me that Dr. B decided their time in the months of July-Sept was better spent progressing P, K, and the two B trials.
Not true. CTIX also stated that the Brilacidin platform will be negotiable for partnerships and deals pending the results of the two on going P2 trials. P may be winning the race at the moment, but it is not the only horse running.
Canoma, your discouragement is understandable when you have a lot of money invested in something which "seems" to be a bad investment. This having been my first biotech investment I am also disappointed that the timetables I had for my money are not the time tables which were realistic for a biotech, but I have also realized that my disappointment is due to my naivete, not due to failures on CTIX's part. Do not let the banter about delays fool you. CTIX has been progressing the drug pipeline within the expected times industry timelines. (see the chart link I am posting below. BK that also answers the question you had for another poster .)
Sure, things can go faster, but that is based on factors that are both within and outside of company control. The big one that everyone thinks is 100% in CTIX control is money. I argue that is only partially true. CTIX has demonstrated that they have been able to manage their funds well when it has been in their control. The part out of their control is share price and new investment. The company has/is relying upon share price to execute funding agreements so a result of the targeted takedown, by way of an fallacious article and lawsuits, tanked the value and therefore stalled and increased durations to accomplish the trials. I argue that this type of delay was/is out of the company control, because they are not going to take drastic measures which will hurt the company long term, just to get a potential boost short term. So with less value available in the share price management then focused on how to adjust plans to maximize the speed of progress with pushing forward on the drug(s) which will have the greatest chance of securing that necessary funding through a buyout or partnership. This is where we are at now.
Long story short is, I believe that CTIX has made the best of the circumstances which they have been faced with. They have continued to make actual, meaningful, company progress to bring drugs closer to the point of generating real value in the share price, all the while doing within industry standard timetables. So keep the faith, so to speak, because as soon as a deal is signed for P CTIX will have the funds necessary to accelerate the remainder of the pipeline and us share holders will get those coveted gains we have been patiently waiting for.
https://pbs.twimg.com/media/CselIwzWAAE0AaN.jpg:large
Not having access to new and effective antibiotics has exacerbated the gargantuan problem we are facing with drug resistance....
No, I am seeing things from a cost to benefit viewpoint. If money and funding is the issue, and since uplist/institutional investors are never a guarantee, it was pertinent to keep moving things forward with the resources they had at the time. Spending the money required to run the trials on BOD members just to secure the POTENTIAL to expedite approvals, the POTENTIAL to uplist, and the POTENTIAL institutional investors may come along was not the correct decision. Leo and Menon still had it within their power to continue progress knowing that, although it was going to be slower, they could advance the company to the point where it then became pertinent to take on the extra financial cost of more BOD members. The risk and burden of taking on more cost was always there, so they made the decision to delay that risk as long as they could and only take it on once they were in the position to start securing additional funding through partnerships. Which is were we are now in 2016.
As far as 'bite from Biden', I don't know what you are referring to because I am positive that there has been no public communication from the VP's office recognizing CTIX. I be very happy if there was, but there is not. Jim Boheim is nice to have in our ballcourt (pun intended), but we all know that his affiliation is not going to be the catalyst to attract executive talent to CTIX.
That's all well and good, but 2 years ago CTIX didn't have the trail data completed which they have now. They were smart enough to know that it was not feasible to attract the level of talent that they have now when they lacked the completion of the successful trials. That or they'd have had to offer a a much higher compensation package to attract talent to a riskier company. So that money was better sent advancing the pipeline and securing top end candidates later at a more reasonable price.
Good try though...
I don't know, but it was only thirteen business days ago that it was announced they were going to pursue the sites that have now opened up. That is not that much time to finalize agreements, set up trial protocols and recruit patients, especially if it is at multiple locations. My guess is that things are in process and will be there soon, but it takes time.
I'd also like to point out that nothing CTIX is working on can be accomplished in a matter of weeks. Preparing for trials takes setting up agreements with host sites, establishing trial protocol and training staff, establishing purchasing and invoicing agreements for all the entities involved, completing and preparing all the documentation necessary, completing and preparing the inventory of the drug itself, and recruiting patients, to just name a few steps. For all those on this board that actually have a job that entails doing anything in the real world other than sitting at a computer all day on stock chat boards, then it is pretty clear that the business of running drug trials is a complex and time consuming process.
So in the time period of July and August CTIX has announced they are preparing for the phase 2b Prurisol Trial in order to start in the late third quarter/early fourth quarter, they have received a large number of new sites to expand the B-Om trial into to expedite it, they have given information that the first B-UP patient is looking very promising, they have announced the initiative to start the K phase 2 ovarian cancer trial in the fourth quarter, and the new president has laid the groundwork for the short term path forward for the company: complete the B and P phase 2 trials to leverage the successful trial data into a partnership(s).
If you think that none of this is of interest, then I wonder what you will ever find interesting about this company. Seems to me that your comments are either uninformed or are purposefully negative. Either of which don’t bode well for credibility as a poster.
I'd like to remind everyone, and any new investors who may be reading and not posting, that Leo has stated many times over the years that CTIX was not looking to partner or sell their drugs until they felt that they have maximized the value of them. I am sure it is highly likely that CTIX could partner or sell just about any of the drugs right now, as-is, but they will not receive as good a price for them as they will with the later stage trial data. Plus as the drugs succeed in later trials risk is reduced, and reduced risk for BP is worth lots of additional money. Leo is a shareholder and Menon is a shareholder; if they are confident that the drugs are working well, and that they have enough funding to continue pursuing trials for the next year, what motivation do they have to diminish potentially massive value just for the sake of partnership in the short term?
I am fully aware that CTIX does not currently have the funding to get any of the drugs through a phase 3 and to market, but they have sufficient funds for a year (even at current share prices) to continue trials and increase the value of the drugs for the future partnership/sale. Yes, more money now may allow for more speed on development, but that will likely only be through a crappy deal and defeat the purpose of maximizing value. Plus, if the plan reaches its time limit and doesn't work to get a better deal, then that tells me the management's backup scenario is that they will then partner or sell a drug for less money in order to keep solvent. It would not be ideal to have to do that, but I think that is a worthwhile gamble for the potential of stellar returns upon future trial success.
This is why I do not put any weight to the continued statements that CTIX can't find a partner, or that Leo has screwed up, or that somehow they are going to go bankrupt. They are choosing to continue down this short term path (which I admit is painful as a shareholder to see paper losses) in order to create a better long term gain for all of us.
This is the type of CTIX dialogue I have been missing lately. Thank you Biodoc and KMBJN.
I'll bite too:
Most large institutional investors have risk profiles which they must adhere to and internal rules that do not allow purchase of stock on the lesser exchanges. Hence the concerted and illegal effort by Mako, Rosen and others to tank the stock price and keep CTIX from uplisting. Once CTIX uplists it becomes much harder to short and manipulate share price because large institutional ownership can buy up most of the remaining float and then share price becomes much more steady. This significantly reduces the opportunity to make money on price fluctuation. Longs win, shorts lose.
Once again Leo drops an easter egg for those who are paying attention:
"Finally, Brilacidin has anti-inflammatory properties that may accelerate and promote clinical healing."
In the past he told us that performing the B Ulcerative Proctitis trial is contingent on the B-Oral Mucositis trial demonstrating the anti-inflammatory properties. We know that they are moving forward with plan for that trial in March. Now he is flat telling us that B HAS that property in this PR!!
Folks, we have an obvious blockbuster of a drug platform in B. IMO it is only a matter of when, not if, that CTIX secures a lucrative deal on B
Wrong on all accounts:
1) Trial progression is the literal demonstration of a drug being successful. If a trail fails, the drug no longer advances and does not get to market. Successful phase 1 trials lead to phase 2 trails. Successful phase 2 trials show the drug is working which leads to the phase 3 trial to dial it in for the maximum results. Successful phase 3 typically leads to market approval.
2) Good management keeps focused on the steps necessary to secure funding and execute trials while navigating the complex FDA regulations to pave the way for advancement and approval.
3) The pipeline equates to advancing share price because the larger and more diverse it is, the greater chance one of the drugs will succeed and bring in revenue and increase the value of the company.
4) Potential equates to both successful trials and advancing share price. CTIX purposefully performs the pre-clinical trials in models that have been used by drugs with proven efficacy to minimize the risk of failure and provide the best possible indication of how well a drug will work in humans (i.e. Purisol). The indication of the drugs potential directly equates to the chances of success trials and success in trials leads to advancing share price. Potential is what most biotech investors are investing in when they buy a company's stock. If there is not any potential for success then there is no reason to invest.
Mr. Market (institutional investors, not retail) is just waiting for the illegal shenanigans and false information that have occurred with CTIX to be cleared up before they can follow their internal investing rules and buy into the winning company called Cellceutix.
I'd say you are totally wrong. CTIX is on Dana Farber's radar, they are on the Mayo Clinic's radar, they are on MD Anderson's radar, they are likely still on Pfizer's radar, and they are on the radar of an undisclosed BP testing topical uses of Brilacidin. My guess it that they are on many investment firms radar's too and when the lawsuit is properly dismissed, and the share price recovers to get CTIX uplisted, we will see significant money being invested and a nice share price climb. Leo know's he has the goods and is moving forward with or without a desireable share price.
It is accurate in discussions because both investors and Leo himself have discussed actual valuation numbers based on factual and accurate market data. Knowing what the existing approved psoriasis drugs are generating and the market size it is easy to see that P is not factored into the share price at all. That's as accurate as any discussion can get without a sealed licensing deal or a completed buyout agreement.
The cold hard facts are just hard to swallow for some. As your post so clearly points out, CTIX has been and is continuing to be validated by a third party: the FDA. They don't just give this stuff out to anyone that applies, they give it to drugs that are demonstrating positive results. Does this mean that they are all working as well as expected, maybe maybe not. However, it does mean that they are performing well enough to justify extra attention and special treatment in the eyes of the FDA. That is fact enough for me to be bullish on CTIX.
It has already been discussed that P is not priced into the stock price at all. According to some opinions K is still unproven and B is the lead candidate now, so that means that if P fails the downside is little to none. The risk is in favor of upside and I reiterate my statement: buy, buy, buy.
Buy, buy buy. CTIX is a winner. Drugs have progressed at excellent levels of speed from laboratory testing to clinical trials. CTIX is not losing money and is in fact performing most tasks for less than the estimates in every 10Q and less than the median costs of most trials. CTIX is frugal. In 3 years the company has gone from one clinical trial to 4 and more to come in the near term. I challenge anyone to find factual proof that this is not a significant accomplishment for so small a company with so little spending, especially considering the current low share price, which is one of the main sources of funding.
That is simply not true. If they have established the primary safety endpoint but see that the "potential efficacy signals add up to nothing" (your words) why would the Dana Farber teams want to extend the trial and keep wasting their time and resources? Why would Cellceutix even allow them to continue the trial any longer than necessary if they were not seeing promising efficacy results? That would be utterly foolish to waste more time and money on nothing new, would it not?? I have seen many opinions on this board that CTIX will greatly benefit from finishing the trial and getting results published. Leo knows this. The investing community seems to also believe this. So why would CTIX be crazy enough to keep the trial going??
BTW, these are all rhetorical questions. I don't actually want any answers.
The BULK of the data is from the pre-clinical. The FDA is not going to grant Orphan Drug Status on a cancer cell line based on the response from one patient in an safety trial. It could be a coincidence that the patient was stable during that time. (Disclosure: I do not believe that, but it is certainly possible). Having the data from one patient is a bonus and helps supplement the pre-clinical data.
Now when there are 11 ovarian cancer patients at multiple dosing levels, that can generate enough data points to make a case for ODD.
Fair enough. Thanks BK.
Yes I understand that. What I was asking aloud was how the stability coincided with the dosing regimens. For example; was it stable starting during the first cycle? If it was that would tell us that the disease was no longer considered stable during the 4th cycle. Again, that is just an example.
I assume these are answers we will not be able to see until official completion of the trial and release of top line data. I was just throwing some thoughts on the wall to see what other more medically savvy posters may or may not think.
Well, considering the trial design was for stage 4 patients that had exhausted other treatment options, I would say that keeping a pancreatic cancer stable for three months when only having four cycles of K (four months of treatment if I am correct) is a pretty damn positive sign that K is working to a very good level. I am curious though, what is the timing of the stable disease as compared to the timing of the dosing? Was it concurrent, was it after the final dosing, or did it happen in a trailing manner as doses were administered? I don't know if that level of information has become available yet.
I'd just like to point out that the up-list is contingent on the share price at this point. Nasdaq does not care who is on the board as long as they meet the criteria of independent. Leo had those pieces in place and just lost out on the timing of the share price fluctuations. (I will not bother to take the discussion any further into the criminal activity that drove the price below up-list needs).
It seems like all that you can be upset about is the handling of PR's. Sure it would be nice to have a professional PR firm helping, but Leo is looking at cost to benefit here. The PR's can always improve, but BP doesn't care about the nuances of the quality of the PR's issued; they care about the drugs working. Plus most institutional investment is typically banned by internal rules from investing until the ticker is on the the bigger boards. It is no fun waiting, but things are moving forward regardless. My suggestion is that if people are so concerned about the holy grail of up-listing, then it will benefit us all to continuously focus on the positives (which are many) and not the negatives (which are few) of CTIX. If the SP needs to be higher then we need to present it to new investors more attractively then is being done.
Next, why should Leo hire a COO onto the payroll to help him work the finances? Many posts here have laid out the facts over and over at how well those have been handled when it comes to paying for and moving the drugs through trials. This is a nice to have, but not a must have at this point and only drains financing from other items.
Last, the peer reviewed journal article is already in process. I assume that with the 20 years you've spent investing that you are aware that these articles take a lot of time to be reviewed and critiqued before they are published. They don't happen over night.
Thank for posting the numbers in a clear way to make the compelling argument that fears of massive dilution are still unfounded at this point. I find it funny that when making an argument about the financial stability of CTIX posting both the past and future financial numbers don't seem to matter to some. Seems to me that makes the financing and dilution argument based in emotion and not fact. Strange way to present one's case.................
Yes, you are missing the fact that the finances are solid well into next year and possibly beyond with how frugal management has been. With all the continued catalysts coming and with all the trials progressing nicely, there is no reason for management to RS just to get a short term bump. Leo has seen first hand how well the RS has played right into the hand of traders and manipulation and is smart enough to only consider RS as a VERY last resort. It's painful to be long and still sitting at these prices when there is so much value in this company as we speak. It will get there, just have to keep patient for the continued good to come. Beating the RS dead horse, which at this point has already decayed and turned to dust, only helps the ones who want to spread the FUD.
Karen, I apologize in advance if I already missed this explanation, but can you fill me in on what the y axis of the graph is showing? My unsolicited advice would be to have the y axis as a percentage of completion of the trials. Thanks.
Excellent response.
Here's a theory that popped into my head when reading BK's information on the extensions to the patents of the generics in combo with K: could the choice have been influence by Sanofi/Zydus? Are they possibly one of the BP's which Leo has been talking to and they want to lay the ground work to a future partnership/buyout by revitalizing one of their generics?? Seems to me that extended patents and revenue are very desirable items to a company. Or maybe I totally misunderstand the patent details.........anyway just a brain fart I had.....
I read this email from Leo and his confidence in his comapny and their pipeline is just painfully obvious. It is also crystal clear that he is a class act. He does not get mad, mean, or upset with an author who is misrepresenting Ctix. He just calmly points out the error in the argument and moves on. That's a quality CEO. Calm and rational discussion. It's clear to me he has nothing but his company, the shareholders, and most importantly the people who stand to benefit from the pipeline in his mind as he moves CTIX forward. I'm for one am glad to have him at the helm of this ship. I'm
I'd also like to add, that if a BP or two are already interested in B and then Menon goes to a conference where he is meeting and talking to other potential suitors, that strengthens Leo's position. It's like many analogies in life; a sports draft, dating, getting job offers, etcetera. If multiple parties have interest in you, you have upper hand in the negotiations. If Menon makes a good connection with another interested pharmaceutical firm as a result of this speech, maybe that's the catalyst for a BP to put some significant money on the table at a level Leo will accept. Just looking at the potential positives here, not the negatives.
Strong work Sox. Factual information for successful uplisting and other SEC reporting data is the magnetic pressure we need to breakup and disperse the pesky, convection inhibiting, magnetic field on our star. The good news is that these concentrations of magnetic flux typically decay in a matter of months, so there will not be too much time left before awesome trial news is released and this phenomena is gone.