Recent activities 10/25/2014 23:25:44 $
Well there are certainly trade-offs. To be flat out better would require at least being equal or better in all areas and better in at least one area.
If B requires fewer doses but D has better 28-day results, doctors might tend toward prescribing D for patients they don't believe will have compliance issues with the 7 doses over B up until the point, if ever, resistance becomes a significant issue for D.
So maybe not so much in terms of approval but more so revenue.
Stock Message Board
No worries when CTIX hits $9 I plan to upgrade so I can send private messages instead of public. By Thanksgiving I hope!
Are there plans for the data to be submitted to a peer reviewed journal or have they already?
I agree, as long as there are no surprises, I prefer to get what information is available sooner then wait for the complete picture.
I just don't think that's the norm. And care does have to be taken, you don't want to mislead investors so there is some level of certainty required before declaring something a success from a cya standpoint, which I dare say Elrich is more keen on than Menon.
Yes, sorry about that
I don't disagree with your assessment of Sierra as a "sleazy blog," but I do not think CTIX is, as yet, an acquisition target because Leo knows the value of CTIX and the price he would demand is higher than any major pharmaceutical would be willing to pay at this time.
So I am referring to a partnership deal and I think GSK has some problems that differentiate them from other pharmas that are merely facing "patent cliffs."
1. Glaxo's U.S. pharmaceutical sales have fallen 16% since 2009.
2. Sales of new therapies, Breo Ellipta and Anoro Ellipta, intended to replace lost revenue have been disappointing.
3. Analysts predict earnings will tumble 17% this year.
4. Advair, the company’s best-selling asthma treatment, is slumping as it faces new competition.
5. Company paid a $3 billion fine in 2012 to resolve U.S. criminal and civil investigations that it failed to report clinical data for Avandia, and marketed other drugs for unapproved uses.
6. Reforms may mean the sales force no longer has the proper incentives to push Breo and Anoro.
7. Glaxo's head of North American pharmaceuticals under pressure to increase U.S. drug sales.
Several pharmas are facing the patent expiration problem in the near future, but Glaxo is in dire straits as we speak. If Glaxo does enter the bidding to partner with CTIX on B then the problems I have enumerated above can only serve to strengthen CTIX's bargaining position. Glaxo sorely needs a billion-dollar drug in the U.S. market. The nice thing is Glaxo needs CTIX more than CTIX needs Glaxo, no matter what they do or don't do.
I actually favor the endpoint releases in stages. Moving the share price $1-$2 every week to 2 weeks is very stable and would create bases of support in blue sky territory rather than a huge jump without opportunity to create significant support. It also fills time until other news events are ready to occur without the inevitable slide, stop sweeping or large profit sell off so often accompanying large swift moves when there is a news void. It keeps the focus on company progression as well as SP appreciation. The idea that more can come at any time helps the basing and creation of meaningful support. JMO
CTIX
Thanks meulch,... very interetsing!
"It is of primary importance for the drug to start working during this time".
Agreed. BK pointed that out.
My point,... Who cares if D's results are better at day 4 and B picks up on day 5?
B is a 1 day dose and D is a 7 day dose.
B is superior because it requires only 1 dose, right?
Did you mean to say secondary in # 1,2,3?
Just to touch on one more thing here as I think the importance of the fact that we met the primary endpoint has already been highlighted.
The secondary endpoints are still important. I see three possibilities:
1. We met the primary endpoints
2. We didn't meet the primary endpoints
3. Cellceutix doesn't know if we met the primary endpoints yet and they were too excited to announce that we met the primary endpoint to wait
I think #3 is the most likely, especially given that this was our first efficacy results I can forgive the lack of detail, so long as there are no surprises.
Just to put it a bit more succinctly, the FDA would never approve a drug for the treatment of ABSSSI without a statistical comparison to another currently approved drug 48-72 hours after treatment is initiated. This is based on the guidance they have issued, and they tend to follow their own guidance (or be more strict).
It is of primary importance for the drug to start working during this time period.
Comparing a 1 dose regimen of Brilacidin to a 7-day/dose regimen of Daptomycin after 3 days isn't unfair, it is a flaw/weakness of Daptomycin that it requires 7 doses.
It would be like saying it's unfair to not approve some new ABSSSI wonder drug that starts working after only 8 months of treatment because it's being compared to a drug that starts working in 3 days. Of course it's fair, the whole point is to work quickly.
That being said, there are secondary outcome measures, and while not as important as the primary outcome measure, they are still important. Given the commentary from Leo and past phase 2a data, while there is no guarantee, I think we can be reasonably confident these secondary endpoints were met.
I suspect they were excited to release the PR, and hope to see a confirmation on secondary endpoints in the coming week. But hoping for more data as investors is often futile until the data can be published in a way to bring as much attention from the scientific community (i.e. at a related conference like the one in April). They don't really like hearing stuff that they've already heard at these conferences, so it is partially in our interest for the data to be kept private until then.
Of course that doesn't mean that Cellceutix won't be looking to partner in the meantime, they can sign NDAs and share the data while still presenting it for the first time at April's conference.
This from the 8-K "daptomycin is a drug marketed by Cubist Pharmaceuticals under the brand name Cubicin. Cubicin sales in the first half of 2014 totaled $447 million"
The value of CTIX's entire company is ~337 Million. Am I wrong in saying that if "B" can take 50% of "D's" yearly sales the market cap and share price could be ~30% higher than it is currently? Assuming, you ignore any multiple which is usually assigned to an earnings stream and ignore income from other indications and ignore "P" and "K" entirely?
A one time dosing antibiotic would be huge in veterinary medicine. Very difficult getting compliance with owners giving medications and pets taking their medication. There is an antibiotic called Convenia that is a one time dosing but this is a Depo product and stays in the body for 2 weeks. Causes too many side effects. Brilacidin is out of the body in less than 24 hours quick kill and not around to cause side effects. Would be a great product. Isn't Dr. Menon a vet
someone ask him what he thinks.
I agree.
Yeah I'm hyped up!! Give me a nibble of cheese and I want to whole wheel!
They didn't pose an interesting question: all promising pharma development companies are potential acquisitions. There is not a single person on this board who doesn't know that, nor doesn't know that GSK is one of many potential acquirers. Most big pharmas, not just GSK, are facing patent cliffs.
What they did do was try to start a rumor. The sleazy blog tried the same thing last year with Keryx Bio. The "secret acquirer" they claimed: GSK.
Hopefully, we'll hear about the other secondary endpoints in the next couple of weeks. I'd think they would know about any relapses or patients requiring antibiotic intervention after day 7. If there were relapses later in the study, I seriously doubt Leo would have gone so far out on a limb. My sense is that all is good.
Well there are certainly trade-offs. To be flat out better would require at least being equal or better in all areas and better in at least one area.
If B requires fewer doses but D has better 28-day results, doctors might tend toward prescribing D for patients they don't believe will have compliance issues with the 7 doses over B up until the point, if ever, resistance becomes a significant issue for D.
So maybe not so much in terms of approval but more so revenue.
Stock Message Board
No worries when CTIX hits $9 I plan to upgrade so I can send private messages instead of public. By Thanksgiving I hope!
Are there plans for the data to be submitted to a peer reviewed journal or have they already?
I agree, as long as there are no surprises, I prefer to get what information is available sooner then wait for the complete picture.
I just don't think that's the norm. And care does have to be taken, you don't want to mislead investors so there is some level of certainty required before declaring something a success from a cya standpoint, which I dare say Elrich is more keen on than Menon.
Yes, sorry about that
I don't disagree with your assessment of Sierra as a "sleazy blog," but I do not think CTIX is, as yet, an acquisition target because Leo knows the value of CTIX and the price he would demand is higher than any major pharmaceutical would be willing to pay at this time.
So I am referring to a partnership deal and I think GSK has some problems that differentiate them from other pharmas that are merely facing "patent cliffs."
1. Glaxo's U.S. pharmaceutical sales have fallen 16% since 2009.
2. Sales of new therapies, Breo Ellipta and Anoro Ellipta, intended to replace lost revenue have been disappointing.
3. Analysts predict earnings will tumble 17% this year.
4. Advair, the company’s best-selling asthma treatment, is slumping as it faces new competition.
5. Company paid a $3 billion fine in 2012 to resolve U.S. criminal and civil investigations that it failed to report clinical data for Avandia, and marketed other drugs for unapproved uses.
6. Reforms may mean the sales force no longer has the proper incentives to push Breo and Anoro.
7. Glaxo's head of North American pharmaceuticals under pressure to increase U.S. drug sales.
Several pharmas are facing the patent expiration problem in the near future, but Glaxo is in dire straits as we speak. If Glaxo does enter the bidding to partner with CTIX on B then the problems I have enumerated above can only serve to strengthen CTIX's bargaining position. Glaxo sorely needs a billion-dollar drug in the U.S. market. The nice thing is Glaxo needs CTIX more than CTIX needs Glaxo, no matter what they do or don't do.
I actually favor the endpoint releases in stages. Moving the share price $1-$2 every week to 2 weeks is very stable and would create bases of support in blue sky territory rather than a huge jump without opportunity to create significant support. It also fills time until other news events are ready to occur without the inevitable slide, stop sweeping or large profit sell off so often accompanying large swift moves when there is a news void. It keeps the focus on company progression as well as SP appreciation. The idea that more can come at any time helps the basing and creation of meaningful support. JMO
CTIX
Thanks meulch,... very interetsing!
"It is of primary importance for the drug to start working during this time".
Agreed. BK pointed that out.
My point,... Who cares if D's results are better at day 4 and B picks up on day 5?
B is a 1 day dose and D is a 7 day dose.
B is superior because it requires only 1 dose, right?
Did you mean to say secondary in # 1,2,3?
Just to touch on one more thing here as I think the importance of the fact that we met the primary endpoint has already been highlighted.
The secondary endpoints are still important. I see three possibilities:
1. We met the primary endpoints
2. We didn't meet the primary endpoints
3. Cellceutix doesn't know if we met the primary endpoints yet and they were too excited to announce that we met the primary endpoint to wait
I think #3 is the most likely, especially given that this was our first efficacy results I can forgive the lack of detail, so long as there are no surprises.
Just to put it a bit more succinctly, the FDA would never approve a drug for the treatment of ABSSSI without a statistical comparison to another currently approved drug 48-72 hours after treatment is initiated. This is based on the guidance they have issued, and they tend to follow their own guidance (or be more strict).
It is of primary importance for the drug to start working during this time period.
Comparing a 1 dose regimen of Brilacidin to a 7-day/dose regimen of Daptomycin after 3 days isn't unfair, it is a flaw/weakness of Daptomycin that it requires 7 doses.
It would be like saying it's unfair to not approve some new ABSSSI wonder drug that starts working after only 8 months of treatment because it's being compared to a drug that starts working in 3 days. Of course it's fair, the whole point is to work quickly.
That being said, there are secondary outcome measures, and while not as important as the primary outcome measure, they are still important. Given the commentary from Leo and past phase 2a data, while there is no guarantee, I think we can be reasonably confident these secondary endpoints were met.
I suspect they were excited to release the PR, and hope to see a confirmation on secondary endpoints in the coming week. But hoping for more data as investors is often futile until the data can be published in a way to bring as much attention from the scientific community (i.e. at a related conference like the one in April). They don't really like hearing stuff that they've already heard at these conferences, so it is partially in our interest for the data to be kept private until then.
Of course that doesn't mean that Cellceutix won't be looking to partner in the meantime, they can sign NDAs and share the data while still presenting it for the first time at April's conference.
This from the 8-K "daptomycin is a drug marketed by Cubist Pharmaceuticals under the brand name Cubicin. Cubicin sales in the first half of 2014 totaled $447 million"
The value of CTIX's entire company is ~337 Million. Am I wrong in saying that if "B" can take 50% of "D's" yearly sales the market cap and share price could be ~30% higher than it is currently? Assuming, you ignore any multiple which is usually assigned to an earnings stream and ignore income from other indications and ignore "P" and "K" entirely?
A one time dosing antibiotic would be huge in veterinary medicine. Very difficult getting compliance with owners giving medications and pets taking their medication. There is an antibiotic called Convenia that is a one time dosing but this is a Depo product and stays in the body for 2 weeks. Causes too many side effects. Brilacidin is out of the body in less than 24 hours quick kill and not around to cause side effects. Would be a great product. Isn't Dr. Menon a vet
someone ask him what he thinks. I agree.
Yeah I'm hyped up!! Give me a nibble of cheese and I want to whole wheel!
They didn't pose an interesting question: all promising pharma development companies are potential acquisitions. There is not a single person on this board who doesn't know that, nor doesn't know that GSK is one of many potential acquirers. Most big pharmas, not just GSK, are facing patent cliffs.
What they did do was try to start a rumor. The sleazy blog tried the same thing last year with Keryx Bio. The "secret acquirer" they claimed: GSK.
Hopefully, we'll hear about the other secondary endpoints in the next couple of weeks. I'd think they would know about any relapses or patients requiring antibiotic intervention after day 7. If there were relapses later in the study, I seriously doubt Leo would have gone so far out on a limb. My sense is that all is good.
