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Agreed...will the trial be designed to show that I wonder?
From the discussions on the phase I, the soligenix treatment is about half as effective as B-OM is expected to be and a mouthwash can be done at home and probably at a much lower cost than an IV. I suspect if OM is typically as painful as it was for my father, rinsing three times a day will not be a problem from a compliance perspective, especially if it provides relief. What is intriguing to me about this is that if B-OM proves to be effective, that will be 2 out of 2 for Brilacidin in Phase II trials....I would say some BP is going to really want that drug (and all of its indications) in their pipeline!
Yesss! I have been waiting and hoping for this trial to begin....come on B-OM, be a huge success for CTIX shareholders and those suffering from this terrible problem!! Leo is coming through on his promise to catch back up....good to see this. My father had terrible OM from throat cancer back in the early 1990s and had to rely on a feeding tube as a result. Ice chips were the only thing that gave him any relief and that was minimal and very very temporary...if B-OM works as it has indicated in pre-clinicals it will help many people.
Thanks Miles....could not agree more. The science and the trials are progressing and as small biotechs go, it is actually quite amazing.
The Next four to six weeks should be interesting....to start, we have ASCO next week. We were told B-OM would begin enrollment by the end of May so there should also be news on that issue. Then in June is the meeting with FDA on B Phase III, we should hear additional information about the U of B trial and the Prurisol Phase II should begin. Uplisting somewhere in those timeframes could happen as well....then there is always the potential for surprise announcement....could be a very rewarding first half of the summer!
Here is the schedule I found...what step is most important to CTIX?
June 12
Preliminary additions & deletions for Russell Global, Russell 3000® and Russell Microcap® Indexes
June 19 & 26
Updates to the list of additions & deletions
June 29
Final membership lists posted for Russell Global, Russell 3000®, Russell 1000®, Russell 2000®, Russell Midcap® and Russell Microcap® Indexes
After today there are five trading days left in May (due to Memorial Day) and we have ASCO at the end of the month. That means we should also be hearing about the commencement of B-OM and also the submittal of the Phase II Protocol by the U of B principal investigator......according to the most recent updates.
I'm right with you BioHedge...I have another investment that has seen wild swings due to unpredictable interactions and delays with the FDA and finally yesterday, there was progress. I actually thought the outcome would have happened almost two years ago. I am glad I decided to stay long and weather the storms. I have the same view of this little gem....the science is so strong that these minor delays (in comparison to the other I mentioned)are simply that...delays.
I am in this long term since I want to see what happens when the science progresses for B Phase III, B-OM, P and K...I came here for K and never imagined it would be in cohort 11 at 750 mg/kg with no significant safety issues. I have decided that I can tolerate the ups and downs in the short term since at this point I would not unload my shares even if the price was $10 before the science is proven. I will patiently watch the science progress and when we know whether the drugs work or not, that's when I will make a change....no need to fret until then.
I didn't say anything about high expectations....we are still in a phase I safety trial....I do think that well reasoned questions by BH could provide some valuable insight into what DF and Shapiro think of the trial and the drug itself..I do agree though that uplisting would make the most of the conference and any news on B-OM and P if it could happen before then.
Let's hope BioHedge can make it to the conference....he would be excellent as well at picking Shapiro's brain.
Potential Catalysts in the next few weeks...
UPLIST
B-OM Phase II Trial Commencement
ASCO
U of B submittal of protocol
Anyone have any others to add?
Not sure if posted already, but there is an interesting article about public funding of antibiotic development just posted on the CTIX facebook page.
This was on the other message board regarding medical devices.....interesting that they are producing and sending Brilacidin to the Pharma that inquired....come on Leo, get that Phase III started!
"I asked Leo about the medical device group study of B and what the status was. He replied..
That is ongoing and as we've said a licensing deal is possible once Brilacidin is approved for an indication. We are meeting with the FDA approximately at the end of June to discuss the ABSSSI Phase 3 trial. In the meantime we have been sending the Pharma Brilacidin for more testing."
Agreed....the science is legit and strong....Harvard Dana Farber does not team with sketchy partners and FDA does not grant QIDP status to sketchy drugs....Menon knows how to take pre-clinical studies results and make them work in humans.....that's why DF is on board and that is why B is proving itself...we will know about B-OM in short order and also P....I have confidence that Menon believes he has these indications figured out as well and will be reporting positive results by the end of 2015.
I thought DF asked them to prepare a presentation back in the Jan/Feb timeframe....I assumed the ASCO participation was going to be that presentation....but you know what happens when you assume....
Once again BioHedge, you bring it all to the appropriate level and viewpoint....I am thrilled to be an investor in this little gem along side you......
The PR makes two points that I find interesting....first is thanking DF for "providing us with exciting data as we move forward" and the second is "we believe that the evidence compiled from trials to date suggests that we have one of the most promising cancer drugs in Kevetrin". Hopefully these statements will be confirmed with the release of the abstract tonight for the ASCO conference. The company seems very optimistic about K and what they are seeing....now that we are this far along in the trial, I am kind of glad DF has been meticulous about the trial....
I could not resist the prices and market cap any longer and jumped in with a small purchase.....anxious to hear what Friday and the future will bring.
When I first read that they were saving the P21 results for the appropriate venue, I could not help but think they wanted to wait for uplisting and then release this information to get the most bang for the buck. I could be wrong, but this additional information in the 10Q on P21 increases at higher doses and the fact that the 10-Q further supports the NASDAQ uplist from a financial perspective has me even more convinced that is what is in the plans.
Time to Retire.....I could swear I heard you say the following just a day or two ago....."I agree. I predict a steady climb to 4.50 within the next 2 weeks. Going to get ugly for the shorts. Have a good night Bobby". Did you not say that? Did you not get enough cheap shares and are hoping to get more before the uplist, next significant PR or the K results at ASCO? Based upon the inconsistency of your posts, it is difficult to take anything you say seriously. Nice try though.
The fact that Leo has not reacted by issuing a PR to counter act the drop in the price is hopefully a good sign in that he knows what is coming soon.
That darn QIDP....it was coordinated with the FDA to make the share price go up....who knew?
George...you have done a 180 on the issue of K being a single agent therapeutic....can you share what changed your mind?
Thanks Pete and good to hear from you again. I agree that uplisting may result in a SP jump, but it should not be looked at as the basis for the real value coming to fruition since it will likely be shortlived...only the pipeline and results can do that for this company....and we will know relatively soon on some of those fronts....should be interesting.
BioH...you show up at just the right time and remind me of the key concepts to investing in Biotech....thanks and glad to hear from you. I plan on holding this little gem until we know what the science will provide for those that are suffering....
Kelt....you make me smile....glad you pipe up every once in a while.
Nano....I literally was just looking at the chart for that company and in September 2010 the price reached 8.12...on January 24th, 2011 (four months later) the price was 4.88....a 40% drop. I don't know if they were on the NASDAQ at the time, but the volatility we are seeing is not unusual for a small biotech as indicated in the example. In the past, I would panic and sell when the price dropped that much...not anymore....this science is just too compelling to not stay and see what happens....we already have Dana Farber funding K and we have a QIDP from FDA....
Here you go....second article down.
http://seekingalpha.com/user/21116141/instablog
BioHedge....you still here?
Could not agree more 1400....I keep asking why Dana Farber would want to conduct another presentation at ASCO if there was nothing of note to report. I have studied other successful biotechs that started out in the single digits and every one of them had significant price fluctuations...since I am long, I expect this volatility to occur and do not get too excited about it. If K and B prove to be what they appear to be at this point patience will pay off.
The latest Ellaruth instablog has an interesting exchange with Ten Bagger on Brilacidin.....data from ECCMID was amazing and confirms the potential for B to be a huge player.
See BK's note below....nothing strange about the end of June....if it was Halloween, that might be strange.
I find it frustrating to read people's posts characterizing 9 months between Phase 2b and Phase 3 as "delayed." Frustrating to the point I don't even want to read or post here. No matter how many times it's pointed out that the time between trial phases is 9 to 12 months, people keep calling the Brilacidin-ABSSSI trial as delayed. That nonsense started 4 months ago.
As for Brilacidin and the QIDP, what we are waiting for are the terms of the QIDP. The normal time between trials is 9 months to a year, and the FDA requested additional data due to the QIDP and the need to determine what types of accelerated trials and review should apply. This is not a delay, this is additional data to SPEED the trial. As I have pointed out again and again, there are 3 different areas the expedited program that results from a QIDP designation: 1) breakthrough therapy designation, where a new type of drug is a major improvement over current therapies; 2)fast-track with accelerated review, where the FDA cuts the review time between trial phases by about 1/2, which includes rolling review where review takes place during the trial; 3) priority review, where the FDA applies all its resources for final review toward approval.
The QIDP involves more initial review in order to greatly shorten the time required for the remaining trial phases. Again, this is not a delay, it is part of the normal review process.
I know...its terrible how a small company like CTIX can be approaching a phase III and several phase II trials for a new compound like B and be financed by Dana Farber in a long term study for a cancer drug that looks to hold real promise....presenting at ASCO for a second time and uplisting soon...what an embarrassment.
Well...if we uplist to NASDAQ this week and then P21 results are released and are as good or better than Leo hinted at...this could get interesting...I keep asking myself why they would want to present the same information at ASCO again? Something must be important to present in a large forum or why bother (and why would ASCO select them)? I hope my suspicions are validated!
That would be great, but based upon ASCO rules I thought were not allowed to release new results. Perhaps P21 results would be considered differently since it is a biomarker and not actual clinical trial results...??
Catalysts coming:
NASDAQ Uplist
B-OM Phase II enrollment starts
P - Phase II Trial starts
K - 11th Cohort starts
K - Release of P-21 Results (could happen)
K - ASCO Presentation
B - Phase III protocol FDA approval
K - U of Bologna AML Phase II Trial starts
Partnership/Buyout Announced
What else?
Barry Schecter was on the BOD already from back in September if I remember correctly....
he seems to have a decent background for what CTIX is trying to do...see the link below:
http://www.fleyedocs.com/vision-eye-institute/barry-a-schechter-m-d-f-a-a-o/
I pay close attention to everything you (and several others) say BH...I want to know exactly what you think so please don't hold back. I am long as well and will wait until the science proves itself. However, the one thing I keep coming back to in my mind is that Leo and Dr. Menon have stated they do not plan to take these drugs to market and do not want to become a large pharma (if my memory is correct).
BH...I respect your opinion on this issue and hope that these members perform beyond your expectations. Can it be rectified over time or is there a requirement that the elected members stay on for a certain time frame?