Yes, he did. Well sort of...
As I recall he said (sometime in early 14) that he might run the tests after cohort 7.
Then he more recently said something to the effect that he intends to ask for those tests after this (c8) cohort.
I don't expect to see much detail for K until after R&R.
Of course, I am on the record for being all in favor of being wrong on that point.
He!!s bells, if they give us B anytime in next 2 months this should take off. MTA, BOD, K&P after that
Another possibility is you may be reading too much into study completion dates, much as some of us, me included did when the completion date was November 2013. Currently, IMO as I don't know for sure, the study completion dates for primary outcomes are pushing forward with each new cohort accounting for MTD final cohort. The primary outcomes and that data is included in the final data date for November. Secondary outcomes would be collected 6 months after the final doses of the last cohort, the expanded cohort establishing MTD.
Even if Cohort 8 establishes dose limits, Cohort 9 will roll back to 165 mg/m2 and enroll 6. If 1 or less experiences a dose limiting toxicity then then there will be one more confirmation cohort of up to 12 patients. This extends the study for primary outcomes another 6 months and makes the total number of cohorts 10. As stated below, if one or more of the patients shows a DLT, then that becomes the maximally administered dose and the final cohort is rolled back to the level of cohort 6.
"Primary Outcome Measures:
Maximum Tolerated Dose (MTD) of Kevetrin [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
A dose will be declared the MTD if at least 1 patient out of 6 patients experience a dose limiting toxicity (DLT) at the highest dose level below the maximally administered dose. Once an MTD has been established, up to 12 additional patients may be enrolled at the MTD dose level for confirmation of safety.
The maximally administered dose is if 1 or more of 6 patients experience a DLT."
I hope everyone sees now why I truly hope the DLT does not occur in cohort 8, but cohort 9 or later. A safe cohort 8 all but assures an MTD above 200 mg/m2 and well above the anticipated efficacy range of 100 to 200 mg/m2.
http://www.clinicaltrials.gov/ct2/show/NCT016...amp;rank=1
CTIX Stock Message Board http://investorshangout.com/Cellceutix-Corpor...TIX-87375/
A wise man once said...
Quote:
The Catalyst News Cycle tends to render technical analysis as useless as teats on a Boar Hog from time to time. The release of P21 data WILL BE one of those times
R&R.
leo and menon are not going to R & R to exchange strudel recipes. leo and especialy menon would not say anything about updating info on the compounds unless he had something. at least that has not been his history. it just depends if dr menon can shake his minders. i love good news seems some people have trouble tolerating it or want to shave cents off the share price.
CTIX is showing real strength given the run to date. Given Leo's PRs and the stock movement, I'm expecting good news from the RR presentation.
That said, I'm not nearly as sanguine about the general market and economy. I just initiated several short positions in technology (supply chain mostly and memory manufactures). I think the market is WAY overvalued and we're coming into the two worst months for the market.
Even with a market dislocation (my opinion only), I expect CTIX to be resilient and with good news to preform very well.
Should be an interesting few months! Good thing football season is here to take some of my attention of the markets
HA! I keep wondering if I will have the cajones to get up there and speak to L and M. We'll see. Being a small time investor, I think I'd rather they spend their time with real investors.
well you are going to find out aren't you? if menon is there you will.
or a .02 cent drop
That's what I'm thinking too...
It looks like lunch is over and trading will commence. We are very likely to see what action above $2.10 looks like.
Soon.
Go CTIX!
I keep having to circle back to the latest change in primary completion dates and study completion dates on clinicaltrial.gov. In the past they always extended the dates by about 6 months, leaving a 6 month gap between (ex. Primary completion April 2014, study completion Oct 2014) we assumed this 6 month gap was for a final cohort at MTD for up to 12 patients.
The last change has September as the Primary completion date. If you put any weight towards that date, it means they expect to reach DLTs in September, start of cohort 9 (my guess was cohort 10 based on my rudimentary calculations). Fine. But why is the study completion date November? That doesn't add up to me. That would mean there is no final cohort at MTD (because it would take 6 months per the protocol).
To me this means one of two things: Either they are really bad with dates/don't care about what's published here because it will just change at a future date OR something else is brewing, like they have enough data to move forward onto future trials. That is the K elephant in the room for me.
Thanks Karin.
Your friend needs to call his brokerage and have his account limits adjusted. Many accounts have a default setting that limits certain types of trades on new accounts. Some can't trade penny stocks, some can't trade options. Some have limits on size of trade. Some don't allow pre and post market. Some only allow pre market at 6am eastern while others allow 4am eastern. Just have him call the broker and adjust his preferences.
Most can be adjusted with a phone call except for Options trading which might require some additional paperwork. That can usually be done online.
In Reply to 'jok'
Question for the board; i have a friend who is trying to buy some shares this morning he says his brokerage won't let him put in an order for more than 10,000 shares. Is that possible?
Thanks
jok
i hope shrinkage and MTD so we can open this trial up in phase 2. people in desperate need. some that have posted on this board that are now gone. and don't forget babies with retinoblastoma. breakthrough and orphan.
Leo said they were running P21 after the last cohort.
I'm getting a bit excited about R@R 2014 coming up. I am planning on attending. In reviewing last year's presentation, I can read this line over and over and over...
"•Kevetrin activated p21 in 4 out of 5 patients treated with 20 or 30 mg/m2"
What will we learn this year?
It looks like someone is trying to cap it at $2.10 ...
I think this is going up to at least 2.15 today
That would be epic!