CTIX Stock Alert 08/19/2014 19:27:28 $CTIX
$700 million would be my estimate for B, period, all indications, given a favorable p2b. I don't think that is too low at this point. Others do, and that is okay. After p3 and the trials for the other indications, 2 billion or so. So is it worth the wait and the additional dilution? What is the risk of B not doing so well v. other indications?
BigK There was a message in those 30kg being manufactured.
Why would he tell us that?
CTIX Stock Message Board http://investorshangout.com/Cellceutix-Corpor...TIX-87375/
We have seen the $2 barrier before... several times... Even moved past it and fallen back time and again... Will be interesting to see if this time a decisive move past and a hold beyond is in order... after a very long consolidation period... and many material developments... maybe???... the time is near...
http://clinicaltrials.gov/show/NCT02101216
Cellceutix Corporation has created a new chemical entity for the treatment of psoriasis, termed Prurisol™, which is an ester of abacavir. This first-in-human study of Prurisol (abacavir acetate) is being performed to evaluate the pharmacokinetics, safety and tolerance of a single oral doses of Prurisol administered to healthy volunteers and the bioequivalence to abacavir sulfate (Ziagen). This study will be followed by a 505(b)(2) Phase 2 trial in patients with moderate to severe plaque psoriasis.
An exciting time to be a CTIX shareholder without a doubt!
$CTIX News, SEC filings, FDA trials, misc., and chart:
SEC filings: http://www.sec.gov/cgi-bin/browse-edgar?compa...getcompany
OTCQB: http://www.otcmarkets.com/stock/ctix/quote
Press Releases: http://cellceutix.com/category/press-release/
Recent News: http://finance.yahoo.com/q/h?s=CTIX+Headlines
Seeking Alpha focus articles on CTIX: http://seekingalpha.com/symbol/CTIX
Clinical trials: http://clinicaltrials.gov/ct2/results?term=ce...rch=Search
Management: http://cellceutix.com/team/
Product Pipeline: http://cellceutix.com/pipeline
Company Address:
100 Cumming Center, Suite 151-B
Beverly, MA 01915
978.236.8717 Phone
978.921.6564 Fax
E-mail: info@cellceutix.com
CIK: 0001355250
Weekly chart:
Good luck all.
Is today's PR a change for Prurisol, or a typo?
On the last PR about Prurisol we got the usual quote:
Quote:
Upon receipt of the final report Cellceutix will schedule a meeting with the FDA to advance Prurisol into a Phase 2/3 clinical trial as quickly as possible. -Link
But in today's PR:
Quote:
Prurisol has recently completed a Phase 1 clinical trial and is being readied for a Phase 2 trial. -Link
Are we now looking at a Phase 2 trial instead of a Phase 2/3 trial? Or is this a typo?
I'm happy either way, just as I was happy with the change from the Proof Of Concept to the Phase 1 crossover trial.
A Phase 2 is cheaper, and if it meets its endpoint, an excellent point for a partnership or buyout. With so much going on for Cellceutix with Brilacidin, this could make sense.
But probably just a type as it wasn't in the main part of the PR.
66 lbs equals >220,000 courses of various B. That would be >220 trials with 1000 or more enrolled.
In my mind, there is a possibility that they are looking to go straight to market on a BTD. >220K courses would represent 50% market penetration for all MSRA caused ABSSSI hospitalizations in the US.
http://www.ashpadvantagemedia.com/id/resource...demand.pdf
But, what do I know. Best not to get carried away with parsing the meaning of enough B to treat 500K cases at the single dose of .8 mg/kg.
What? And leave a future $150 on the table?...Okay!
NR, I really like the partnership side because in my opinion it trumps both institutional investment as well as up-listing. The reason being "revenue". This is the 900 pound gorilla at this point. Of course, if Novartis comes in with a buyout of $200 per share we can all take off for Tahiti!
GO CTIX
My thinking is some of this volume is from watchers and fence sitters piling on but the beginning last week and then this week is likely due to info that is available to some and not necessarily leaking but people are putting things together. Top it off with everyone who knows about CTIX has been expecting it to move eventually and got caught off guard.
Regarding your number 2...this could be why they are producing 60+ lbs. of Brilla. MTAs already planned or expected.
BigK do you think 66lbs of Brilacidin
will be enough or should we order some more
?
No more cry baby . 150k shares says we move higher!
Exactly!
Considering market, B-ABSSSI license alone is worth $350 million to $500 million ($700 million is within range but a little on the high side IMO), including $35 million to $100 million upfront.
We now have 6 other 1/2 billion to billion dollar indications/formulations for B:
Brilacidin-OM
Brilacidin-Ocular
Brilacidin-Otic
Gram Negative Bacteria
Candidiasis
Diabetic Foot Infections/Ulcers
That's a lot of Phase 2/3 trials to move, so it would be very nice to license ABSSSI and pay for everything else, including K and P.
Loving this action$$$$
Value of a partnership has too many variables to predict with any degree of certainty. Look at Cubist' purchase of Trius and their post phase 3 drug Tedizolid. B is probably worth more than that but it is not as far along, so its a push. $700 million with a successful P2b? That's around $5 a share fully diluted. I recall posting that number early in the year and it still seems good to me.
B could be worth a lot more following Phase 3 and after trials for other indications. Hard to say which path is better for shareholders. It would be nice to bring K and P forward without dilution, but B could bring a couple Billion by waiting. Not my decision, of course, but a fun one to analyze.
Quote:
This time around for CTIX it could be Buy the Rumour and Buy the News.
Why? Because:
1) Start B-OM Phase 2/3 trial within 60 days
2) Announce MTAs for several indications
3) K Cohort 8 update within days, if no DLT then market may respond positively (for a change) now that the safe dose is well above the anticipated efficacy range.
4) Start of P Phase 2/3 in 3 to 4 months (probably January)
5) Preliminary/final report for B Phase 2b within weeks.
6) If single dose high efficacy, announce BTD and expedited approval and Phase 3 rolling review, or if not designated as breakthrough therapy then start Phase 3 pivotal trial within 6 months
7) Probable B-ABSSSI licensee/partner for the next clinical phase.
NR, this is all very true. Only because you didn't mention it, do you have a target value for partnership(s).
$700 million would be my estimate for B, period, all indications, given a favorable p2b. I don't think that is too low at this point. Others do, and that is okay. After p3 and the trials for the other indications, 2 billion or so. So is it worth the wait and the additional dilution? What is the risk of B not doing so well v. other indications?
BigK There was a message in those 30kg being manufactured.
Why would he tell us that?
CTIX Stock Message Board http://investorshangout.com/Cellceutix-Corpor...TIX-87375/
We have seen the $2 barrier before... several times... Even moved past it and fallen back time and again... Will be interesting to see if this time a decisive move past and a hold beyond is in order... after a very long consolidation period... and many material developments... maybe???... the time is near...
http://clinicaltrials.gov/show/NCT02101216
Cellceutix Corporation has created a new chemical entity for the treatment of psoriasis, termed Prurisol™, which is an ester of abacavir. This first-in-human study of Prurisol (abacavir acetate) is being performed to evaluate the pharmacokinetics, safety and tolerance of a single oral doses of Prurisol administered to healthy volunteers and the bioequivalence to abacavir sulfate (Ziagen). This study will be followed by a 505(b)(2) Phase 2 trial in patients with moderate to severe plaque psoriasis.
An exciting time to be a CTIX shareholder without a doubt!
$CTIX News, SEC filings, FDA trials, misc., and chart:
SEC filings: http://www.sec.gov/cgi-bin/browse-edgar?compa...getcompany
OTCQB: http://www.otcmarkets.com/stock/ctix/quote
Press Releases: http://cellceutix.com/category/press-release/
Recent News: http://finance.yahoo.com/q/h?s=CTIX+Headlines
Seeking Alpha focus articles on CTIX: http://seekingalpha.com/symbol/CTIX
Clinical trials: http://clinicaltrials.gov/ct2/results?term=ce...rch=Search
Management: http://cellceutix.com/team/
Product Pipeline: http://cellceutix.com/pipeline
Company Address:
100 Cumming Center, Suite 151-B
Beverly, MA 01915
978.236.8717 Phone
978.921.6564 Fax
E-mail: info@cellceutix.com
CIK: 0001355250
Weekly chart:
Good luck all.
Is today's PR a change for Prurisol, or a typo?
On the last PR about Prurisol we got the usual quote:
Quote:
Upon receipt of the final report Cellceutix will schedule a meeting with the FDA to advance Prurisol into a Phase 2/3 clinical trial as quickly as possible. -Link
But in today's PR:
Quote:
Prurisol has recently completed a Phase 1 clinical trial and is being readied for a Phase 2 trial. -Link
Are we now looking at a Phase 2 trial instead of a Phase 2/3 trial? Or is this a typo?
I'm happy either way, just as I was happy with the change from the Proof Of Concept to the Phase 1 crossover trial.
A Phase 2 is cheaper, and if it meets its endpoint, an excellent point for a partnership or buyout. With so much going on for Cellceutix with Brilacidin, this could make sense.
But probably just a type as it wasn't in the main part of the PR.
66 lbs equals >220,000 courses of various B. That would be >220 trials with 1000 or more enrolled.
In my mind, there is a possibility that they are looking to go straight to market on a BTD. >220K courses would represent 50% market penetration for all MSRA caused ABSSSI hospitalizations in the US.
http://www.ashpadvantagemedia.com/id/resource...demand.pdf
But, what do I know. Best not to get carried away with parsing the meaning of enough B to treat 500K cases at the single dose of .8 mg/kg.
What? And leave a future $150 on the table?...Okay!
NR, I really like the partnership side because in my opinion it trumps both institutional investment as well as up-listing. The reason being "revenue". This is the 900 pound gorilla at this point. Of course, if Novartis comes in with a buyout of $200 per share we can all take off for Tahiti!
GO CTIX
My thinking is some of this volume is from watchers and fence sitters piling on but the beginning last week and then this week is likely due to info that is available to some and not necessarily leaking but people are putting things together. Top it off with everyone who knows about CTIX has been expecting it to move eventually and got caught off guard.
Regarding your number 2...this could be why they are producing 60+ lbs. of Brilla. MTAs already planned or expected.
BigK do you think 66lbs of Brilacidin
will be enough or should we order some more
? No more cry baby
. 150k shares says we move higher! Exactly!
Considering market, B-ABSSSI license alone is worth $350 million to $500 million ($700 million is within range but a little on the high side IMO), including $35 million to $100 million upfront.
We now have 6 other 1/2 billion to billion dollar indications/formulations for B:
Brilacidin-OM
Brilacidin-Ocular
Brilacidin-Otic
Gram Negative Bacteria
Candidiasis
Diabetic Foot Infections/Ulcers
That's a lot of Phase 2/3 trials to move, so it would be very nice to license ABSSSI and pay for everything else, including K and P.
Loving this action$$$$
Value of a partnership has too many variables to predict with any degree of certainty. Look at Cubist' purchase of Trius and their post phase 3 drug Tedizolid. B is probably worth more than that but it is not as far along, so its a push. $700 million with a successful P2b? That's around $5 a share fully diluted. I recall posting that number early in the year and it still seems good to me.
B could be worth a lot more following Phase 3 and after trials for other indications. Hard to say which path is better for shareholders. It would be nice to bring K and P forward without dilution, but B could bring a couple Billion by waiting. Not my decision, of course, but a fun one to analyze.
Quote:
This time around for CTIX it could be Buy the Rumour and Buy the News.
Why? Because:
1) Start B-OM Phase 2/3 trial within 60 days
2) Announce MTAs for several indications
3) K Cohort 8 update within days, if no DLT then market may respond positively (for a change) now that the safe dose is well above the anticipated efficacy range.
4) Start of P Phase 2/3 in 3 to 4 months (probably January)
5) Preliminary/final report for B Phase 2b within weeks.
6) If single dose high efficacy, announce BTD and expedited approval and Phase 3 rolling review, or if not designated as breakthrough therapy then start Phase 3 pivotal trial within 6 months
7) Probable B-ABSSSI licensee/partner for the next clinical phase.
NR, this is all very true. Only because you didn't mention it, do you have a target value for partnership(s).
