CTIX Discussion 08/25/2014 14:30:53 $CTIX
Edit...you might be right...$2.09 just printed.
When daptomycin was in clinical trials, vancomycin was used as the control arm because it was the standard of care.
Now that daptomycin has been proven to be as good as vancomycin one can assume either drug could be used as the control arm.
Daptomycin has not replaced Vancomycin yet because Vanco is cheaper and there are very few incidences of resistance.
If Brilacidin proves to be as effective in a single dose as daptomycin one could make the statement that B is as effective as Vancomycin.
I doubt in the real world of clinical medicine that a physician would give just one dose for such severe infections would be considered inadequate.
The real cost savings would be in 2 day dosing, no need for a PICC line and the costs incurred in the drug delivery and no resistance.
I think Leo is planning to use Brilacidin in severe septicemia caused by such devastating bugs as Klebsiella, Pnuemococcal and other gram negative bacteria.
CTIX Stock Message Board http://investorshangout.com/Cellceutix-Corpor...TIX-87375/
She looks like she wants to close at $2.10
What a strong day today!
You Wrote:
“My reading of the Brilacidin P2A data suggest to me that B is already superior to Daptomycin in terms of safety and efficacy.”
I see others with the same opinion (or hope) on this board. Would you, or anyone else, please elaborate on how the data leads you to suggest that B will show a greater efficacy than D? Based on the published P1 results (link below), B comes close to D in efficacy. I know there were 5 drop outs that were likely healed. If they are factored in, does mid-dose become superior? I know non- resistant, single dose or 3 dose are huge for adoption by the medical community, but does B have a chance to win head to head on efficacy too???
Thank you for your valuable contribution to this board.
Let's clear up some misconceptions about B and the Poly assets once and for all. This is not a stupid question, but I do see some posts that I think are not quite clear on the topic. Here is the way I understand it, anyone please correct me if I am wrong:
First off, the collapse of Polymedix was due to a sequence of events that sent the company into a rapid death spiral. First, the company's anti-stroke drug delparantag, has some serious adverse effects (hypotension) in its phase 2 trial which effectively killed its clinical trial progress at that time. Leo made comments in last year's R&R that they are in a great position to play "monday morning quarterback" with delparantag, to analyze and look at a potential reformulation that would address the hypotension SAEs. If anyone can do it, my money is on Dr. Menon and Dr. Jorgensen.
Anyways, some investors were outraged and claimed that the company downplayed these concerns while reaping the benefits of a suspiciously timely stock offering. Secondly, the failure of delparantag clinically had obvious dramatic impact on the share price causing it to plummet, and simultaneously killed the prospects for future financing for Brilacidin, which was all but ready to start the FDA approved phase 2B trial. This is where Leo so expertly picked up and carried the ball across the goal line for CTIX shareholders.
In a sense, Polymedix was very similar to where CTIX is now, in market cap (roughly 220 million at one point), a very respected pipeline, and respected (up until that point) management, also at a similar stage of product development. But the similarities end there.
We are fortunate to be invested in a company with a very progressive and proactive CEO. He is moving the entire pipeline along as swiftly as he possibly can, with the protection of the Aspire agreement to see all the current trials through to their end to give the pipeline a chance to bring some revenue back to the company and shareholders. I know some people are not fans of Aspire, but it is an absolutely critical component to providing solid financial footing for this young company so that all 3 main compounds can be developed safely without the risk of a financial crash such as the one that happened at PYMX.
Finally, with regards to your question as to how CTIX got these assets for so cheap, and why didn't a big pharma step in to buy them if the potential here was so good, well the bottom line is CTIX was able to move very rapidly to make a stalking horse bid on these assets, and the reality is that many bigger pharmas would need more deliberation and approvals to make such a move. Leo and Dr. Menon clearly were on the same page and moved with speed to get their bid in as quickly as possible.
Also, this bid happened during the summer months, where IMO a lot of the right people needed at big pharma were either on vacation or asleep at the wheel before they realized the opportunity that they had missed on. Still, from a skeptic's point of view - it is fair to say that this purchase is "too good to be true", and I believe part of this skepticism is why the market has essentially assigned no value to the poly assets since CTIX has acquired them.
But I believe this lag in the market positions smaller investors like us with higher risk tolerances an opportunity to get in early, get in cheap, and get in often before the phase 2B Brilacidin results are known. If B works as we all hope on a single dose, then just from Brilacidin alone the return on the Poly investment for shareholders should be a 10-20 bagger as soon as Leo can cut a deal with big pharma to partner up for a phase 3 trial. This could set up for a very dramatic move up in stock price as Brilacidin would come one step closer to maturation and commercialization.
All IMO, like I said, someone please correct me if I am wrong or I mis-understood the whole PYMX story, I know there are some former PYMX holders here that have all the gory details down better than I do.
Bottom line is, we are on the cusp of potentially validating one of the greatest under the radar acquisitions that you could ever come across in biotech, IMO. If B is a success in ABSSSI, and in all the other indications that the company is working on testing it, then the potential revenue this drug can bring in will be fantastic. Perhaps the recent volume and SP action recently are an indication of the increasing awareness of this potential.
Somehow these answers won't satisfy. Oh well.
No trades in the last 20 minutes... Wow...
Great point Daubs....
That statement Leo snuck in there is much more relevant than all of us think. Why do you end a basic PR saying enrollment is complete with...oh by the way..."we are now in the process of manufacturing 30kg (66.138pounds) of Brilacidin for future clinical trials which we plan for multiple forms of serious infections"
This Law360 article about the Polymedix debacle may shed some light on why they went under: PolyMedix Hid Drug's Flaws Before $20M Stock Deal, Suit Says
http://www.law360.com/articles/356300/polymed...-suit-says
Apparently they misled investors about their anticoagulant drug in order to raise money to fund the Brilacidin trials.
snip> The April 2011 stock offering was designed primarily to fund another PolyMedix experimental compound, called PMX-30063, that is intended to treat bacterial skin infections, according to the suit. The plaintiffs called that compound “the company’s only remaining chance at redemption.”
The suit seeks "tens of millions of dollars" allegedly lost by investors who purchased PolyMedix stock between March 7, 2011, and May 10, 2012. The complaint brings claims under the Securities and Exchange Act of 1934. <snip
PapaS all imo and in brief the trial the former owner ran utilized a longer regimen,(too long), and B showed efficacy, however had issues with blood pressure. Dr Jorgenson was retained to help CTIX with the current trial and most likely tweak anything from the prior company's first run at it.
B has successfully made it through the current trial without any SAE's stopping the trial prior to it's completion. The regimen was decreased in the three arm trial. Two single days, and one three day.
At this point the trial is 100 percent completed enrollment. With that said the report is due most likely within 60 days, and the PR said they have now manufactured 65 pounds of Brilacidin. wink wink.........
If like many others have speculated and the B has shown equivalence good, if it has shown superiority.....even bigger numbers could come
Yes I have a little over 10k shares wish I had more but I will be happy with what I have for now.
Gov, I'm with the ctix family have been long and accumulating for about 1.5 yrs on p and k but I am leary about b and its acquisition. The term was stalking horse but that too raises issues. I just feel like there is a missing piece. Hope I'm wrong and this takes off I would not stare that gift horse in the mouth.
if i remember correctly there was some big deal going on in europe so this flew under the radar. also CTIX was chosen as the stalking something or other. the test conducted in canada, ukraine and russia was hugely successful. read the posts from around the time of the bio conference in san francisco.
I read the PR's now and a year ago when I had a position in ctix what I don't get is the statement
Less than two years ago, PolyMedix had 28 employees, a market capitalization of $227.4 million and was rated as “outperform” by a well-known investment banking firm.
- See more at: http://cellceutix.com/cellceutix-acquires-pol...WencG.dpuf
If polymedix was an outperformer and B was a game changing drug how does polmedix go bankrupt? Ok say bad management then why what seems to be only one suitor in buying the 9 pipeline compounds?
See news here for Polymedix asset purchase...
http://cellceutix.com/cellceutix-acquires-pol...llcIZ.dpbs
i suggest you access the company website and your question will be answered plus much more if you make the effort and take the time to read them,
CTIX bought the assets from a bankrupt company called Polymedics. They didn't let Brillacidin go, it was already gone. Lots of info on this going back to last year. Check last September posts and CTIX news.
I have what may be a dumb question but I'll ask anyway. If I remember correctly 'B' was picked up in the purchase of a failing company, why if it has so much potential why did that company let it go for next to nothing?
Edit...you might be right...$2.09 just printed.
When daptomycin was in clinical trials, vancomycin was used as the control arm because it was the standard of care.
Now that daptomycin has been proven to be as good as vancomycin one can assume either drug could be used as the control arm.
Daptomycin has not replaced Vancomycin yet because Vanco is cheaper and there are very few incidences of resistance.
If Brilacidin proves to be as effective in a single dose as daptomycin one could make the statement that B is as effective as Vancomycin.
I doubt in the real world of clinical medicine that a physician would give just one dose for such severe infections would be considered inadequate.
The real cost savings would be in 2 day dosing, no need for a PICC line and the costs incurred in the drug delivery and no resistance.
I think Leo is planning to use Brilacidin in severe septicemia caused by such devastating bugs as Klebsiella, Pnuemococcal and other gram negative bacteria.
CTIX Stock Message Board http://investorshangout.com/Cellceutix-Corpor...TIX-87375/
She looks like she wants to close at $2.10
What a strong day today!
You Wrote:
“My reading of the Brilacidin P2A data suggest to me that B is already superior to Daptomycin in terms of safety and efficacy.”
I see others with the same opinion (or hope) on this board. Would you, or anyone else, please elaborate on how the data leads you to suggest that B will show a greater efficacy than D? Based on the published P1 results (link below), B comes close to D in efficacy. I know there were 5 drop outs that were likely healed. If they are factored in, does mid-dose become superior? I know non- resistant, single dose or 3 dose are huge for adoption by the medical community, but does B have a chance to win head to head on efficacy too???
Thank you for your valuable contribution to this board.
Let's clear up some misconceptions about B and the Poly assets once and for all. This is not a stupid question, but I do see some posts that I think are not quite clear on the topic. Here is the way I understand it, anyone please correct me if I am wrong:
First off, the collapse of Polymedix was due to a sequence of events that sent the company into a rapid death spiral. First, the company's anti-stroke drug delparantag, has some serious adverse effects (hypotension) in its phase 2 trial which effectively killed its clinical trial progress at that time. Leo made comments in last year's R&R that they are in a great position to play "monday morning quarterback" with delparantag, to analyze and look at a potential reformulation that would address the hypotension SAEs. If anyone can do it, my money is on Dr. Menon and Dr. Jorgensen.
Anyways, some investors were outraged and claimed that the company downplayed these concerns while reaping the benefits of a suspiciously timely stock offering. Secondly, the failure of delparantag clinically had obvious dramatic impact on the share price causing it to plummet, and simultaneously killed the prospects for future financing for Brilacidin, which was all but ready to start the FDA approved phase 2B trial. This is where Leo so expertly picked up and carried the ball across the goal line for CTIX shareholders.
In a sense, Polymedix was very similar to where CTIX is now, in market cap (roughly 220 million at one point), a very respected pipeline, and respected (up until that point) management, also at a similar stage of product development. But the similarities end there.
We are fortunate to be invested in a company with a very progressive and proactive CEO. He is moving the entire pipeline along as swiftly as he possibly can, with the protection of the Aspire agreement to see all the current trials through to their end to give the pipeline a chance to bring some revenue back to the company and shareholders. I know some people are not fans of Aspire, but it is an absolutely critical component to providing solid financial footing for this young company so that all 3 main compounds can be developed safely without the risk of a financial crash such as the one that happened at PYMX.
Finally, with regards to your question as to how CTIX got these assets for so cheap, and why didn't a big pharma step in to buy them if the potential here was so good, well the bottom line is CTIX was able to move very rapidly to make a stalking horse bid on these assets, and the reality is that many bigger pharmas would need more deliberation and approvals to make such a move. Leo and Dr. Menon clearly were on the same page and moved with speed to get their bid in as quickly as possible.
Also, this bid happened during the summer months, where IMO a lot of the right people needed at big pharma were either on vacation or asleep at the wheel before they realized the opportunity that they had missed on. Still, from a skeptic's point of view - it is fair to say that this purchase is "too good to be true", and I believe part of this skepticism is why the market has essentially assigned no value to the poly assets since CTIX has acquired them.
But I believe this lag in the market positions smaller investors like us with higher risk tolerances an opportunity to get in early, get in cheap, and get in often before the phase 2B Brilacidin results are known. If B works as we all hope on a single dose, then just from Brilacidin alone the return on the Poly investment for shareholders should be a 10-20 bagger as soon as Leo can cut a deal with big pharma to partner up for a phase 3 trial. This could set up for a very dramatic move up in stock price as Brilacidin would come one step closer to maturation and commercialization.
All IMO, like I said, someone please correct me if I am wrong or I mis-understood the whole PYMX story, I know there are some former PYMX holders here that have all the gory details down better than I do.
Bottom line is, we are on the cusp of potentially validating one of the greatest under the radar acquisitions that you could ever come across in biotech, IMO. If B is a success in ABSSSI, and in all the other indications that the company is working on testing it, then the potential revenue this drug can bring in will be fantastic. Perhaps the recent volume and SP action recently are an indication of the increasing awareness of this potential.
Somehow these answers won't satisfy. Oh well.
No trades in the last 20 minutes... Wow...
Great point Daubs....
That statement Leo snuck in there is much more relevant than all of us think. Why do you end a basic PR saying enrollment is complete with...oh by the way..."we are now in the process of manufacturing 30kg (66.138pounds) of Brilacidin for future clinical trials which we plan for multiple forms of serious infections"
This Law360 article about the Polymedix debacle may shed some light on why they went under: PolyMedix Hid Drug's Flaws Before $20M Stock Deal, Suit Says
http://www.law360.com/articles/356300/polymed...-suit-says
Apparently they misled investors about their anticoagulant drug in order to raise money to fund the Brilacidin trials.
snip> The April 2011 stock offering was designed primarily to fund another PolyMedix experimental compound, called PMX-30063, that is intended to treat bacterial skin infections, according to the suit. The plaintiffs called that compound “the company’s only remaining chance at redemption.”
The suit seeks "tens of millions of dollars" allegedly lost by investors who purchased PolyMedix stock between March 7, 2011, and May 10, 2012. The complaint brings claims under the Securities and Exchange Act of 1934. <snip
PapaS all imo and in brief the trial the former owner ran utilized a longer regimen,(too long), and B showed efficacy, however had issues with blood pressure. Dr Jorgenson was retained to help CTIX with the current trial and most likely tweak anything from the prior company's first run at it.
B has successfully made it through the current trial without any SAE's stopping the trial prior to it's completion. The regimen was decreased in the three arm trial. Two single days, and one three day.
At this point the trial is 100 percent completed enrollment. With that said the report is due most likely within 60 days, and the PR said they have now manufactured 65 pounds of Brilacidin. wink wink.........
If like many others have speculated and the B has shown equivalence good, if it has shown superiority.....even bigger numbers could come
Yes I have a little over 10k shares wish I had more but I will be happy with what I have for now.
Gov, I'm with the ctix family have been long and accumulating for about 1.5 yrs on p and k but I am leary about b and its acquisition. The term was stalking horse but that too raises issues. I just feel like there is a missing piece. Hope I'm wrong and this takes off I would not stare that gift horse in the mouth.
if i remember correctly there was some big deal going on in europe so this flew under the radar. also CTIX was chosen as the stalking something or other. the test conducted in canada, ukraine and russia was hugely successful. read the posts from around the time of the bio conference in san francisco.
I read the PR's now and a year ago when I had a position in ctix what I don't get is the statement
Less than two years ago, PolyMedix had 28 employees, a market capitalization of $227.4 million and was rated as “outperform” by a well-known investment banking firm.
- See more at: http://cellceutix.com/cellceutix-acquires-pol...WencG.dpuf
If polymedix was an outperformer and B was a game changing drug how does polmedix go bankrupt? Ok say bad management then why what seems to be only one suitor in buying the 9 pipeline compounds?
See news here for Polymedix asset purchase...
http://cellceutix.com/cellceutix-acquires-pol...llcIZ.dpbs
i suggest you access the company website and your question will be answered plus much more if you make the effort and take the time to read them,
CTIX bought the assets from a bankrupt company called Polymedics. They didn't let Brillacidin go, it was already gone. Lots of info on this going back to last year. Check last September posts and CTIX news.
I have what may be a dumb question but I'll ask anyway. If I remember correctly 'B' was picked up in the purchase of a failing company, why if it has so much potential why did that company let it go for next to nothing?
